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38 Trials |  |
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- | Enweida (envafolimab) / 3DMed, Ascletis
New P2 trial: Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer (EUDRACT) - Aug 6, 2025
P2, N=43, Recruiting, Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
- anbenitamab repodatecan (JSKN003) / Alphamab
Phase ? study of JSKN003, a biparatopic anti-HER2 antibody-drug conjugate (ADC), versus physician's choice of chemotherapy in platinum-resistant ovarian cancer (PROC) (Hall 25) - Jul 29, 2025 - Abstract #ESMO2025ESMO_4831;
- 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 (Hall 25) - 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 (Hall 25) - 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 (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3435;
- Enweida (envafolimab) / 3DMed, Ascletis
Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial (Hall 25) - 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 (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2725;
- anbenitamab repodatecan (JSKN003) / Alphamab
Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC) (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2615;
- anbenitamab repodatecan (JSKN003) / Alphamab
Efficacy and safety of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with HER2-positive metastatic colorectal cancer (mCRC) (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2421;
- Enweida (envafolimab) / 3DMed, Ascletis
Neoadjuvant envafolimab combined with chemoradiotherapy in locally advanced rectal cancer: an exploratory, phase II study (Hall 25) - 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 (Hall 25) - 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.
- | JSKN003 / Alphamab, Herceptin (trastuzumab) / Roche
Journal: A biparatopic HER2-targeting ADC constructed via site-specific glycan conjugation exhibits superior stability, safety, and efficacy. (Pubmed Central) - Jun 27, 2025
JSKN003 demonstrated excellent antitumor activity and a favorable safety profile in clinical trials, highlighting its potential as a promising therapeutic option for patients with HER2-positive tumors. These findings suggest that JSKN003 could be a valuable therapeutic strategy with excellent efficacy and safety for HER2-expressing tumors in the clinical setting.
- | 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.
- | 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;
- | 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
- |||| anbenitamab repodatecan (JSKN003) / Alphamab
New P2 trial: JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov) - Jun 2, 2025
P2, N=153, Not yet recruiting, Sponsor: Shanghai JMT-Bio Inc.
- |||||| anbenitamab (KN026) / Alphamab
Enrollment open, Trial primary completion date: Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer. (clinicaltrials.gov) - May 30, 2025
P3, N=880, Recruiting, Sponsor: Shanghai JMT-Bio Inc.
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. Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2026 --> Jul 2025
- |||| 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.
Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2026 --> Jul 2025 Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Jan 2025 --> Sep 2024
- || 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: Jan 2025 --> Dec 2026 | Trial primary completion date: Jan 2025 --> Sep 2024 Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 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
- || KN056 / Alphamab
Clinical, P1 data, PK/PD data, Journal: A phase 1, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of KN056 (a recombinant human GLP-1 variant Fc fusion protein) in healthy Chinese participants. (Pubmed Central) - May 13, 2025
Body weight decreased within seven days of administration, correlating with dose levels, with a mean reduction of -1.68?kg in the 12.0?mg group; however, no significant change in body weight was observed by the end of the study. KN056 demonstrated favorable PK, PD, and safety profiles in healthy Chinese participants, supporting its potential for once-weekly dosing.
- | 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
- JSKN003 / Alphamab
JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trials. (Hall A - Posters and Exhibits; Poster Bd #: 455) - May 1, 2025 - Abstract #ASCO2025ASCO_7457;
P1, P1/2,
The well tolerated toxicity with long-term observation was consistent with prior experience. A confirmatory trial (NCT06751485) is ongoing in all comers at any HER2 expression level to further support JSKN003 as a treatment option in this population.
- 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).
- |||||| anbenitamab (KN026) / Alphamab
Enrollment open: A Phase III Study of KN026 in Combination With HB1801 (clinicaltrials.gov) - Apr 25, 2025
P3, N=520, Recruiting, Sponsor: Shanghai JMT-Bio Inc.
The Part 2 of this study is ongoing (NCT04891198). Not yet recruiting --> Recruiting
- 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.
- JSKN003 / Alphamab
A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumors. (Hall A - Posters and Exhibits; Poster Bd #: 337) - Apr 23, 2025 - Abstract #ASCO2025ASCO_3611;
P1, P1/2
Most pts were heavily pretreated (37.5% had ?3 lines of prior treatment; 45.0% received irinotecan; 67.5% received anti-HER2 therapy; 42.5% received IO therapy). JSKN003 demonstrated promising efficacy in heavily pretreated pts with advanced HER2-overexpressing gastrointestinal tumors, with a manageable and predictable safety profile.
- JSKN003 / Alphamab
JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studies. (Hall A - Posters and Exhibits; Poster Bd #: 7) - Apr 23, 2025 - Abstract #ASCO2025ASCO_3403;
P1, P1/2
The biparatopic HER2 antibody design likely enhanced its binding efficiency and contributed to the observed clinical benefit. These findings support the planned Phase 3 trial to further evaluate its therapeutic potential.
- anbenitamab (KN026) / Alphamab
Longitudinal tissue analysis and correlation of microenvironmental changes with combined immunotherapy and targeted therapy response in metastatic breast cancer. (Hall A - Posters and Exhibits; Poster Bd #: 1) - Apr 23, 2025 - Abstract #ASCO2025ASCO_3306;
P2
The immune response in responsive patients was effectively enhanced, whereas in nonresponsive patients, it was significantly diminished. And higher baseline levels of M?s were associated with therapeutic resistance.
- Sulanda (surufatinib) / Hutchmed, IMC001 / Immunofoco, erfonrilimab (KN046) / Alphamab
Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): A single-arm, phase 1b/2 trial. (Hall A - Posters and Exhibits; Poster Bd #: 447) - Apr 23, 2025 - Abstract #ASCO2025ASCO_2523;
P1/2
Funded by HUTCHMED, ALPHAMAB Clinical Trial Registration Number: NCT05832892 Background: Gemcitabine (G) and nab-paclitaxel (nP) are standard 1L regimen for patients (pts) with unresectable PC, yet the efficacy remains unsatisfactory... These preliminary results showed encouraging anti-tumor efficacy and an acceptable safety profile of S plus K and GnP chemotherapy as 1L treatment for advanced PC.
- 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.
- | 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.
- || erfonrilimab (KN046) / Alphamab, anbenitamab (KN026) / Alphamab
P2 data, Journal: Safety and Efficacy of KN046 in combination with KN026 in Patients with advanced HER2-positive Breast Cancer: a Phase II Trial. (Pubmed Central) - Apr 4, 2025
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. The combination of KN046 and KN026, as a chemo free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pre-treated patients with advanced HER2-positive breast cancer.
- | 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
- 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;
The combination of KN046 and KN026, as a chemo free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pre-treated patients with advanced HER2-positive breast cancer. 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.
- |||||| anbenitamab repodatecan (JSKN003) / Alphamab
Enrollment open: JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov) - Mar 24, 2025
P3, N=228, Recruiting, Sponsor: Shanghai JMT-Bio Inc.
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. Not yet recruiting --> Recruiting
- || erfonrilimab (KN046) / Alphamab, anbenitamab (KN026) / Alphamab
P1 data, P2 data, Journal: Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. (Pubmed Central) - Mar 20, 2025
In the other HER2-positive solid tumor subgroup (n?=?34), the ORR was 52.9% (95%CI 35.1%,70.2%). Thus, KN026 plus KN04 exhibits promising efficacy and acceptable safety profiles in HER2-positive nonbreast cancer, as does the 1st-line treatment for GC.