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- Enweida (envafolimab) / 3DMed, Ascletis, Focus V (anlotinib) / Advenchen, Sino Biopharm
Efficacy and safety of first-line etoposide plus anlotinib and envafolimab in elderly patients with small-cell lung cancer: an open-label, single-arm, phase II study () - Jul 24, 2025 - Abstract #ESMO2025ESMO_4682;
- Cosela (trilaciclib) / Pharmacosmos, Enweida (envafolimab) / 3DMed, Ascletis
Preliminary Results of a Randomized Phase II Trial Evaluating Envafolimab, Etoposide, and Carboplatin with or without Trilaciclib in ES-SCLC () - Jul 24, 2025 - Abstract #ESMO2025ESMO_3809;
- Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab Combined with Recombinant Human Endostatin and Chemotherapy as First-line treatment in metastatic pancreatic cancer: A single-arm,exploratory, phase II trial () - Jul 24, 2025 - Abstract #ESMO2025ESMO_3435;
- IMC002 / Immuneoncia Therap
Enhanced Safety Profile of IMC-002, an Affinity-Optimized Anti-CD47 Antibody: Preclinical and Phase 1a/1b Findings () - Jul 24, 2025 - Abstract #ESMO2025ESMO_2973;
- Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial () - Jul 24, 2025 - Abstract #ESMO2025ESMO_2843;
- Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab and radiochemotherapy for locally advanced cervical cancer:A prospective, single-arm, phase II study () - Jul 24, 2025 - Abstract #ESMO2025ESMO_2725;
- Enweida (envafolimab) / 3DMed, Ascletis
Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: an exploratory, phase II study () - Jul 24, 2025 - Abstract #ESMO2025ESMO_2398;
- Enweida (envafolimab) / 3DMed, Ascletis, Epidaza (chidamide) / Chipscreen
Envafolimab and Chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (B-Enefits/SCOG-B001): A single-arm, exploratory, phase 2 trial () - Jul 24, 2025 - Abstract #ESMO2025ESMO_1949;
- | Journal, Platinum resistant: Combination Therapy for Platinum-Resistant Ovarian Cancer: A Novel At-Home Regimen with Envafolimab, Lenvatinib, and Etoposide. (Pubmed Central) - Jul 14, 2025
P2
Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer.
- || batiraxcept (AVB-500) / Aravive, Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Exelixis
P1/2 data, Journal: Phase 1b/2 study of batiraxcept alone and in combination with cabozantinib with or without nivolumab for advanced clear cell renal cell carcinoma. (Pubmed Central) - Jun 24, 2025
P1b/2
Batiraxcept was well tolerated with promising early efficacy signal when combined with cabozantinib, especially in heavily pretreated patients with ccRCC. The trial was discontinued early due to the sponsor's internal decision.
- | Enweida (envafolimab) / 3DMed, Ascletis
Retrospective data, Journal, Real-world evidence, PD(L)-1 Biomarker, IO biomarker: Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real-World Study. (Pubmed Central) - Jun 17, 2025
Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.
- || IMC002 / Immuneoncia Therap
Trial completion date, Trial primary completion date: A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov) - Jun 16, 2025
P1, N=62, Recruiting, Sponsor: ImmuneOncia Therapeutics Inc.
With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer. Trial completion date: Dec 2026 --> Aug 2029 | Trial primary completion date: Jun 2025 --> Dec 2027
- | Enweida (envafolimab) / 3DMed, Ascletis, sorafenib / Generic mfg.
Journal: A study on the effectiveness and safety of interventional embolization using drug-loaded microspheres in combination with sorafenib and envafolimab for intermediate and advanced renal cell carcinoma. (Pubmed Central) - Jun 13, 2025
Overall, the incidence of adverse reactions in the combination group was greatly decreased than that in the D-TAE group (P<0.05). Drug-loaded microsphere interventional embolization combined with sorafenib and envafolimab has certain efficacy and acceptable safety in treating intermediate and late-stage renal tumor, providing a new treatment option for patients with renal cell carcinoma.
- Cosela (trilaciclib) / Pharmacosmos, Enweida (envafolimab) / 3DMed, Ascletis
Rationale and design of a randomized phase II trial of the first-line treatment of extensive stage small cell lung cancer with the combination of Envafolimab, etoposide, and carboplatin with or without trilaciclib (SMA-SCLC-005 study) (PS-33) - Jun 11, 2025 - Abstract #ERS2025ERS_4489;
- ||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Trial termination, Platinum resistant: AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jun 11, 2025
P1/2, N=12, Terminated, Sponsor: M.D. Anderson Cancer Center
Drug-loaded microsphere interventional embolization combined with sorafenib and envafolimab has certain efficacy and acceptable safety in treating intermediate and late-stage renal tumor, providing a new treatment option for patients with renal cell carcinoma. Completed --> Terminated; PI Request
- | Enweida (envafolimab) / 3DMed, Ascletis
New P4 trial: Neoadjuvant Envafolimab plus Chemotherapy in Locally Advanced Head and Neck Carcinoma: an open-label clinical trial (EUDRACT) - Jun 5, 2025
P4, N=38, Recruiting, Sponsor: Peking University Hospital of Stomatology; Peking University Hospital of Stomatology
- | Enweida (envafolimab) / 3DMed, Ascletis
New P2 trial: Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer (clinicaltrials.gov) - Jun 4, 2025
P2, N=62, Not yet recruiting, Sponsor: Tongji Hospital
- |||| Enweida (envafolimab) / 3DMed, Ascletis
Trial completion date, Trial primary completion date: KN035-BTC: Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (clinicaltrials.gov) - May 30, 2025
P3, N=480, Active, not recruiting, Sponsor: 3D Medicines (Sichuan) Co., Ltd.
Completed --> Terminated; PI Request Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Jan 2025 --> Sep 2024
- | Zeltherva (galinpepimut-S) / SELLAS Life Sciences
Trial completion date, Trial primary completion date: Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov) - May 30, 2025
P1, N=15, Active, not recruiting, Sponsor: 3D Medicines
Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Jan 2025 --> Sep 2024 Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
- || Enweida (envafolimab) / 3DMed, Ascletis
Trial completion date, Trial primary completion date, Monotherapy, MSI-H, dMMR: KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov) - May 30, 2025
P2, N=200, Recruiting, Sponsor: 3D Medicines (Sichuan) Co., Ltd.
Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jun 2026 Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- | segigratinib (3D185) / 3DMed
Trial completion date, Trial primary completion date, Monotherapy: A Monotherapy in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - May 30, 2025
P1, N=42, Active, not recruiting, Sponsor: 3D Medicines (Beijing) Co., Ltd.
Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- | segigratinib (3D185) / 3DMed
Trial completion date, Trial primary completion date, Monotherapy: Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma (clinicaltrials.gov) - May 19, 2025
P2, N=50, Not yet recruiting, Sponsor: 3D Medicines (Beijing) Co., Ltd.
Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Dec 2025 --> Dec 2027
- | Zeltherva (galinpepimut-S) / SELLAS Life Sciences
Trial completion date, Trial primary completion date, Monotherapy: REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov) - May 16, 2025
P3, N=128, Active, not recruiting, Sponsor: Sellas Life Sciences Group
Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Dec 2025 --> Dec 2027 Trial completion date: Mar 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Sep 2025
- Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Neoadjuvant immunotherapy in Patients(Including Elderly and Bleeding) with Locally Advanced Gastric Cancer: FRIENDSHIP-GC-01 Trial () - May 16, 2025 - Abstract #IGCC2025IGCC_983;
All of the patients received neoadjuvant therapy (Envafolimab 300 mg Q3W + SOX (S-1 40mg, Oxaliplatin 130 mg/m2)Q3W )for 3 cycle, followed by surgery, adjuvant therapy (Envafolimab 300 mg Q3W + SOX (S-1 40mg, Oxaliplatin 130 mg/m2)Q3W)for 3-5 cycle...The other aim was to assess organoid,PCT,ctDNA mutations and transcript levels ( RNA-Seq, mRNA) in relation to patient outcome and prognosis to determine which patients are more likely to benefit from immune-combination chemotherapy. We have completed the enrollment of 29 cases, of which 11 patients underwent radical surgery, 4 patients had pCR, and the proportion of pCR reached 36.4%.
- | Enweida (envafolimab) / 3DMed, Ascletis, Erbitux (cetuximab) / Eli Lilly
Trial primary completion date: CEIL: Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer (clinicaltrials.gov) - May 15, 2025
P2, N=198, Recruiting, Sponsor: Sun Yat-sen University
We have completed the enrollment of 29 cases, of which 11 patients underwent radical surgery, 4 patients had pCR, and the proportion of pCR reached 36.4%. Trial primary completion date: Dec 2025 --> Mar 2026
- | Enweida (envafolimab) / 3DMed, Ascletis, Erbitux (cetuximab) / Eli Lilly
New P2/3 trial: A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-?and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - May 6, 2025
P2/3, N=590, Not yet recruiting, Sponsor: Sun Yat-sen University
- || grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
P1 data, Journal, Monotherapy: A phase I dose-escalation and expansion study of RMX1002, a selective E-type prostanoid receptor 4 antagonist, as monotherapy and in combination with anti-PD-1 antibody in advanced solid tumors. (Pubmed Central) - May 2, 2025
RMX1002 was well tolerated and showed a best response of stable disease. RMX1002 500
- Enweida (envafolimab) / 3DMed, Ascletis
Monotherapy of envafolimab in patients with high tumor mutational burden advanced solid tumors: Results from a phase II clinical trial. (Hall A - Posters and Exhibits; Poster Bd #: 242) - May 1, 2025 - Abstract #ASCO2025ASCO_7399;
P2
tTMB could be a useful predictive biomarker for response to envafolimab in patients with pre-treated advanced solid cancer. The Part 2 of this study is ongoing (NCT04891198).
- Enweida (envafolimab) / 3DMed, Ascletis, Fruzaqla (fruquintinib) / Takeda
A phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_7159;
P2
The combination of fruquintinib with envafolimab was well tolerated and demonstrated preliminary clinical activity in advanced or locally advanced OS and STS who had failed to first-line chemotherapy. Enrollment is ongoing and updated data will be presented in the future.
- Enweida (envafolimab) / 3DMed, Ascletis
Efficacy and safety of envafolimab plus platinum-based chemotherapy as neoadjuvant therapy in resectable stage IIb-IIIb NSCLC: A single-arm, prospective, exploratory study. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_6539;
P=N/A
In consist with the results from intravenous anti-PD-1 antibody plus chemotherapy in NSCLC patients, subcutaneous injection of envafolimab with chemotherapy provided a more convenient dose regimen in this population. Chinese Clinical trial information: ChiCTR2400079595.
- Cosela (trilaciclib) / Pharmacosmos, Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab plus docetaxel in combination with or without trilaciclib versus docetaxel in pretreated advanced or metastatic non-small cell lung cancer (NSCLC): Preliminary analysis of an open-label, randomized, phase II trial. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_6469;
P2
PFS data, OS data and and myeloprotection with trilaciclib will be updated in the future. Antitumor efficacy and hematological adverse events during the first treatment cycle.
- Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab combined with albumin-bound paclitaxel and cisplatin in the neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma: A prospective, single-arm, multicenter phase II study. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_5492;
P2
The combination of envafolimab, albumin-bound paclitaxel and cisplatin demonstrates promising pCR rate and acceptable tolerance in patients with LA-ESCC. The trial is ongoing, with further investigation anticipated.
- Enweida (envafolimab) / 3DMed, Ascletis, Focus V (anlotinib) / Advenchen, Sino Biopharm
Efficacy and safety of second-line therapy by envafolimab combined with anlotinib and S-1 in pancreatic cancer patients: A single-arm, phase II clinical trial. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_5489;
P2
This study suggests the advantage of envafolimab combined with anlotinib and S-1 demonstrated encouraging efficacy and tolerable adverse reactions among patients with advanced pancreatic cancer patients . Best overall responses (BOR) of third or above line subgroup or ECOG PS 2-3 subgroup.
- Enweida (envafolimab) / 3DMed, Ascletis, Epidaza (chidamide) / Chipscreen
Envafolimab and chidamide in combination with GEMOX as first-line treatment for advanced and metastatic biliary tract cancer (B-Enefits/SCOG-B001): A single-arm, exploratory, phase 2 trial. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_5430;
P2
Patients with advanced BTCs receive treatment of Envafolimab (400 mg, on day 1) and Chidamide (20 mg orally for twice a week, on day 0, 3, 7, and 10), and GEMOX (gemcitabine 1000 mg/m2, on day 1 and 8, and oxaliplatin 100 mg/m2, on day 1) every 3 weeks for 8 cycles, followed by maintenance treatment with Envafolimab, Chidamide, and gemcitabine until PD, unacceptable toxicity, or patient refusal... The combination of Envafolimab, Chidamide, and GEMOX demonstrated promising efficacy and tolerable adverse reactions in patients with advanced BTC.
- Enweida (envafolimab) / 3DMed, Ascletis, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Efficacy of envafolimab combined with capecitabine and lenvatinib as postoperative adjuvant therapy for radical resected cholangiocarcinoma with high-risk recurrence factors: A phase II single-center prospective study. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_5282;
P2/3
The combination of envafolimab, lenvatinib, and capecitabine demonstrated promising DFS with acceptable toxicity in the adjuvant setting for high-risk cholangiocarcinoma patients post R0 resection. These results highlight the potential of this therapeutic approach and warrant further investigation through randomized controlled trials.
- Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab monotherapy or combination therapy in elderly patients with advanced solid tumors. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_4658;
These results highlight the potential of this therapeutic approach and warrant further investigation through randomized controlled trials. Envafolimab is an efficient, safe and convenient treatment for advanced cancer patients aged 70 and above, especially for those multiple comorbidities and poor ECOG scores.
- Enweida (envafolimab) / 3DMed, Ascletis, Opdivo (nivolumab) / Ono Pharma, BMS, Tecentriq (atezolizumab) / Roche
Safety and efficacy of subcutaneous versus intravenous administration of PD (L)1 inhibitors in patients with solid tumors: A systematic review and meta-analysis. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_4601;
PD(L)1 inhibitors included nivolumab, atezolizumab, sansalimab and envafolimab... SC and IV administration of PD(L)1 inhibitors showed comparable efficacy and safety, supporting SC as a viable alternative to IV in solid tumors.
- Enweida (envafolimab) / 3DMed, Ascletis
First-line envafolimab in combination with recombinant human endostatin and chemotherapy for advanced squamous non-small cell lung cancer: Updated results from a prospective, single-arm, multicenter phase II study. (Hall A - Posters and Exhibits; Poster Bd #: 53) - Apr 23, 2025 - Abstract #ASCO2025ASCO_1741;
P2
Patients received Envafolimab (300 mg, subcutaneously, day 1) and Rh-endostatin (210 mg, continuous intravenous infusion over 72 hours, day 1-3) combined with paclitaxel (175mg/m2, day 1) or albumin paclitaxel (260 mg/m2, day 1), and cisplatin (75 mg/m2 , day 1-3), or carboplatin ( AUC 5, IV, day 1); every 3 weeks for 4-6 cycles, followed by maintenance Envafolimab until disease progression (PD), unacceptable toxicity, or patient refusal... Our results demonstrated that Envafolimab in combination with Rh-endostatin and chemotherapy resulted in favorable clinical outcomes with a manageable safety profile, representing a promising treatment modality as first-line therapy for advanced sq-NSCLC.
- Enweida (envafolimab) / 3DMed, Ascletis
Efficacy and safety of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: A prospective, single-arm, phase II trial. (Hall A - Posters and Exhibits; Poster Bd #: 211) - Apr 23, 2025 - Abstract #ASCO2025ASCO_1623;
P2
Our results demonstrated that Envafolimab in combination with Rh-endostatin and chemotherapy resulted in favorable clinical outcomes with a manageable safety profile, representing a promising treatment modality as first-line therapy for advanced sq-NSCLC. First-line envafolimab in combination with carboplatin and etoposide yielded favorable clinical efficacy with a manageable safety profile for patients with ES?SCLC, representing a promising treatment modality.
- IMC002 / Immuneoncia Therap
Phase 1b dose extension study of a next-generation anti-CD47 monoclonal antibody IMC-002 combined with lenvatinib in patients with advanced hepatocellular carcinoma (HCC). (Hall A - Posters and Exhibits; Poster Bd #: 173) - Apr 23, 2025 - Abstract #ASCO2025ASCO_899;
P1
AI-driven biomarker analysis identified potential predictive value, supporting the need for further investigation in larger clinical trials. Tumor response by CD47 non-specific cell proportion.Cohort A: High proportion (?15%) of 'non-specific' cells; Cohort B: Low proportion (<15%) of 'non-specific' cells.
- | Enweida (envafolimab) / 3DMed, Ascletis, cisplatin / Generic mfg., albumin-bound paclitaxel / Generic mfg.
Journal: Immunotherapy for primary squamous cell carcinoma of the liver: A case report. (Pubmed Central) - Apr 17, 2025
The uniqueness of the present case lies in the patient's receipt of an innovative therapeutic regimen combining envafolimab with albumin-paclitaxel and cisplatin, achieving a sustained partial response over an 18-month follow-up period. This outcome not only offers novel insights for the clinical management of PSCCL but also underscores the importance of multidisciplinary comprehensive treatment in rare tumors.
- | Cosela (trilaciclib) / Pharmacosmos, Enweida (envafolimab) / 3DMed, Ascletis
New P2 trial: Randomized controlled clinical study on the efficacy and safety of first-line treatment of extensive stage small cell lung cancer with combination therapy of trilaciclib, envafolimab, etoposide, and carboplatin (EUDRACT) - Apr 2, 2025
P2, N=52, Recruiting, Sponsor: Shanghai Chest
- | grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma
Journal: Targeting the E Prostanoid Receptor EP4 Mitigates Cardiac Fibrosis Induced by ?-Adrenergic Activation. (Pubmed Central) - Mar 27, 2025
Collectively, this study demonstrates that both CM-EP4 and CF-EP4 contribute to ?-adrenergic activation-induced cardiac fibrosis. Targeting EP4 may offer a novel therapeutic approach for cardiac fibrosis.
- JSKN022 / Alphamab
JSKN022, a first in class multi-specific ADC targeting PD-L1 and ITGB6/8 with an innovative DNA topoisomerase I inhibitor demonstrates encouraging efficacy in preclinical models (Section 15; Poster Board No: 8) - Mar 25, 2025 - Abstract #AACR2025AACR_7966;
Targeting EP4 may offer a novel therapeutic approach for cardiac fibrosis. This preclinical study suggests JSKN022, as a first in class multi-specific PD-L1/ITGB6/8 ADC, might potentially bring in novelty in the therapeutic approach for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors.
- IMC002 / Immuneoncia Therap, amulirafusp alfa (IMM0306) / ImmuneOnco Biopharma
Development of IMC-002, a next-generation anti-CD47 mAb: an affinity optimized antibody with enhanced safety and therapeutic efficacy in preclinical models (Section 36; Poster Board No: 25) - Mar 25, 2025 - Abstract #AACR2025AACR_6998;
These findings provide strong support for its clinical development as a cancer therapeutic. Phase 1a trials confirmed IMC-002's superior safety profile, and ongoing Phase 1b trials are evaluating its efficacy in combination with standard-of-care therapies in patients with HCC and TNBC.
- || Enweida (envafolimab) / 3DMed, Ascletis
P2b data, Journal: A randomized phase 2b study of subcutaneous PD-L1 antibody ASC22 in virally-suppressed, HBeAg negative chronic hepatitis B patients. (Pubmed Central) - Mar 17, 2025
Phase 1a trials confirmed IMC-002's superior safety profile, and ongoing Phase 1b trials are evaluating its efficacy in combination with standard-of-care therapies in patients with HCC and TNBC. Subcutaneous administration of 1.0
- | Enweida (envafolimab) / 3DMed, Ascletis
Trial completion: Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM) (clinicaltrials.gov) - Mar 13, 2025
P2, N=32, Completed, Sponsor: Sir Run Run Shaw Hospital
Subcutaneous administration of 1.0 Active, not recruiting --> Completed
- || Enweida (envafolimab) / 3DMed, Ascletis
P2 data, Journal, Metastases: Efficacy and safety of combining short-course neoadjuvant chemoradiotherapy with envafolimab in locally advanced rectal cancer patients with microsatellite stability: A phase II PRECAM experimental study. (Pubmed Central) - Mar 7, 2025
Minor adverse effects and surgical complications were observed. These preliminary but promising results underscore the potential of this approach and call for further exploration and validation through a randomized controlled trial.
- || Enweida (envafolimab) / 3DMed, Ascletis, Lenvima (lenvatinib) / Eisai, Merck (MSD)
P2 data, Journal: Efficacy and safety of the combination of envafolimab and lenvatinib in unresectable hepatocellular carcinoma: a single-arm, multicentre, exploratory phase II clinical study. (Pubmed Central) - Feb 27, 2025
Furthermore, grade 3 and higher TRAEs occurred in 30%. This study demonstrates that envafolimab in combination with lenvatinib exhibits favourable anti-cancer activity and a manageable safety profile for the first-line treatment of patients with unresectable HCC.
- | Enweida (envafolimab) / 3DMed, Ascletis
Journal, PD(L)-1 Biomarker, IO biomarker: Case report: A case of type 1 diabetes with diabetic ketoacidosis induced by envafolimab treatment in hepatocellular carcinoma. (Pubmed Central) - Feb 17, 2025
We advocate for the establishment of long-term follow-up plans, including regular monitoring for potential irAEs and endocrine function assessments, to address the chronicity of conditions post-ICI treatment. Recognizing the limitations of current understanding, there is a clear call for further research, particularly on identifying biomarkers that may predict adverse reactions to immunotherapy, to guide precision medicine and improve patient safety.