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sotigalimab

Generic: APX005M·Code: APX005M

sotigalimab: developed by 2 companies · 5 clinical trials tracked.

sotigalimab evidence translation

What we can confirm

5 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about sotigalimab, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence6 indications · 0 study sponsors

Related indications

solid tumors such as soft tissue sarcomas, esophageal and gastroesophageal junction ("GEJ") cancers and melanomaDeveloped for oncology (CD40 agonist) with demonstrated activity in multiple difficult-to-treat tumor types, including activity in melanoma patients refractory to anti-PD-(L)1 when combined with nivolumab.Advanced MelanomaMelanomaPancreatic CancerRenal Cell Carcinoma

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
Apexigen, Inc. (APGN)
solid tumors such as soft tissue sarcomas, esophageal and ga…
Phase 2
Pyxis Oncology, Inc. (PYXS)
Developed for oncology (CD40 agonist) with demonstrated acti…
Phase 2
Clinical Trials (5)

Phase Ib Open-Label, Multicenter, Study Evaluating the Safety and Efficacy of 'Switch Maintenance' Combination Immunotherapy Using AB154, AB122, and Sotigalimab in Patients With Metastatic Pancreatic Cancer

NCT05419479·Phase 1/Phase 2
Suspended

Primary endpoint: Dose-limiting toxicities-Phase 1

Interventionalopen46 targetStarted 2022-11Completion 2032-051 site · United StatesJames Cleary, MD, PhD

A Phase I Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma

NCT04495257·Phase 1
Completed

Primary endpoint: Dose-limiting toxicities

Interventionalopen26 enrolledStarted 2020-09Completion 2026-032 sites · United StatesYale University

INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial With and Without APX005M, an Anti-CD40 Agonist

NCT04130854·Phase 2
Completed

Primary endpoint: Pathological Complete Response Rate

InterventionalRandomizedopen58 enrolledStarted 2020-04Completion 2026-014 sites · United StatesUniversity of Texas Southwestern Medical Center

A Phase II Trial Evaluating APX005M (a CD40 Agonistic Monoclonal Antibody) in Combination With Standard-of-Care Doxorubicin for the Treatment of Advanced Sarcomas

NCT03719430·Phase 2
Completed

Primary endpoint: Objective Response Rate

Interventionalopen27 enrolledStarted 2019-03Completion 2025-123 sites · United StatesAlexander Z. Wei, MD

Phase I/II Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral CD40 Agonistic Monoclonal Antibody APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma

NCT02706353·Phase 1/Phase 2
Terminated

Primary endpoint: Safety and Tolerability

Interventionalopen34 enrolledStarted 2017-06Completion 2025-031 site · United StatesM.D. Anderson Cancer Center

Frequently asked questions

Who is developing sotigalimab?

sotigalimab is being developed by Apexigen, Inc., Pyxis Oncology, Inc..

How many clinical trials involve sotigalimab?

BioSniper tracks 5 clinical trials involving sotigalimab.