drugset / Trial / NCT05858736
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
Phase 1
Active not recruiting
18 enrolled
OncoC4, Inc.
Avance Clinical Pty Ltd. · collabOncoC4 AU Pty Ltd · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody. This is a dose escalation study to identify the maximum toxicity dose (MTD) or the recommended phase 2 dose (RP2D).
Timeline
- Start
- 2023-07-11
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AI-061 | Unknown | 200 mg | Intravenous |
| Subject | AI-061 | Unknown | 400 mg | Intravenous |
| Subject | AI-061 | Unknown | 600 mg | Intravenous |
Indications
anus cancer
bile duct cancer
cervical cancer
endometrial cancer
esophageal cancer
fallopian tube cancer
gastric cancer
gastroesophageal cancer
head and neck squamous cell carcinoma
hepatocellular carcinoma
melanoma
non-small cell lung carcinoma
ovarian serous adenocarcinoma
primary peritoneal carcinoma
renal cell carcinoma
urinary bladder cancer