- |||||||||| puxitatug samrotecan (AZD8205) / AstraZeneca
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies (clinicaltrials.gov) - Jun 10, 2024 P1/2, N=340, Recruiting, Data support 750 mg Q3W as the pivotal dose for registrational studies. N=248 --> 340 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
- |||||||||| datopotamab deruxtecan (DS-1062a) / Daiichi Sankyo, AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Pan tumor, Metastases: Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (clinicaltrials.gov) - Apr 25, 2024 P2, N=531, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Mar 2025 --> Aug 2026 | Trial primary completion date: Mar 2025 --> Aug 2026
- |||||||||| Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, rilvegostomig (AZD2936) / AstraZeneca
A phase 3, randomized study of adjuvant rilvegostomig plus chemotherapy in resected biliary tract cancer: ARTEMIDE-Biliary01. (Hall A; Poster Bd #: 169b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3928; P3 Additional endpoints include progression-free survival following recurrence, patient-reported tolerability, and safety. Enrollment has begun, and approximately 200 sites will be recruiting globally across Asia, Australia, Europe, North America, and South America.
- |||||||||| GEMINI-Hepatobiliary: A phase 2 study of novel first-line immuno-oncology-based treatments in patients with advanced hepatobiliary cancers. (Hall A; Poster Bd #: 163b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3916;
P2 Early-phase studies have demonstrated the efficacy of volrustomig (volru; anti-PD-1/CTLA-4 bispecific humanized IgG1 monoclonal antibody [mAb]) in patients (pts) with non-small-cell lung cancer (NSCLC) and renal cell carcinoma, and of rilvegostomig (rilve; anti-PD-1/TIGIT bispecific humanized IgG1 mAb) in pts with NSCLC, along with manageable safety profiles...Pts will be treated with volru as monotherapy or in combination with bevacizumab or lenvatinib...Pts will be treated with gemcitabine + cisplatin with either rilve or volru...The study is currently recruiting at sites in the US, Asia, and Europe. GEMINI-Hepatobiliary master protocol design.
- |||||||||| rilvegostomig (AZD2936) / AstraZeneca
Molecular residual disease (MRD) interception in locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC): MERIDIAN study. (Hall A; Poster Bd #: 433b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3572; Rilvegostomig (AZD2936) is a monovalent bispecific TIGIT/PD-1 antibody that has shown acceptable safety in phase I studies, currently in phase III studies...Exploratory analyses include: ctDNA detection using other assays (HPV DNA, methylated ctDNA), ctDNA detection in part E and beyond W10 in part D, quality of life assessments (FACT-ICM, EORTC-HN43), health economics and radiomics. As of February 2024, 19 patients are recruited.
- |||||||||| rilvegostomig (AZD2936) / AstraZeneca, datopotamab deruxtecan (DS-1062a) / Daiichi Sankyo, AstraZeneca
New P3 trial, Combination therapy, Monotherapy, IO biomarker, Metastases: TROPION-Lung10: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ? 50%) and Without Actionable Genomic Alterations (clinicaltrials.gov) - Apr 10, 2024 P3, N=675, Not yet recruiting,
- |||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Dual immune checkpoint inhibition enhances the anti-tumor activity of trastuzumab deruxtecan in preclinical models (Section 3) - Mar 5, 2024 - Abstract #AACR2024AACR_4155; The anti-tumor activity of T-DXd in combination with volrustomig, a monovalent bispecific antibody targeting PD-1 and CTLA-4, was also assessed in hu-CD34+ NSG mice bearing HER2-low Caki-1 renal cell carcinoma tumors...Pharmacodynamic analysis revealed how the combination of T-DXd and PD-1/TIGIT inhibition increased tumoral NK cells (3.2-fold, P <0.001) and CD8+ T cells (3.8-fold, P <0.001) relative to vehicle. Consistent with findings in syngeneic models, the combination of T-DXd with a bispecific PD-1/CTLA-4 inhibitor also enhanced tumor growth inhibition in a humanised Caki-1 model (121%) compared to T-DXd alone (72%) (P <0.001).ConclusionsThese data provide insight into the clinical activity observed with T-DXd and provide scientific rationale for combination strategies with novel, bispecific IO agents targeting CTLA-4 or TIGIT in addition to the PD-1/PD-L1 axis.
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - Mar 2, 2024 P1, N=175, Active, not recruiting, Consistent with findings in syngeneic models, the combination of T-DXd with a bispecific PD-1/CTLA-4 inhibitor also enhanced tumor growth inhibition in a humanised Caki-1 model (121%) compared to T-DXd alone (72%) (P <0.001).ConclusionsThese data provide insight into the clinical activity observed with T-DXd and provide scientific rationale for combination strategies with novel, bispecific IO agents targeting CTLA-4 or TIGIT in addition to the PD-1/PD-L1 axis. Trial completion date: May 2023 --> Mar 2026
- |||||||||| volrustomig (MEDI5752) / AstraZeneca, rilvegostomig (AZD2936) / AstraZeneca
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Immunomodulating, Metastases: Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (clinicaltrials.gov) - Feb 15, 2024 P2, N=260, Recruiting, Phase classification: P1b/2 --> P2 | Trial completion date: Sep 2025 --> Jul 2026 | Trial primary completion date: Sep 2025 --> Jul 2026 N=180 --> 260 | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Enrollment change, Trial completion date, Trial primary completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - Jun 1, 2023 P1, N=175, Active, not recruiting, Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jul 2026 N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - May 5, 2022 P1, N=212, Active, not recruiting, Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: Jan 2024 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026
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