A Phase 1b/2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Shionogi

Summary

The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab. The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Eligibility Criteria: Key Inclusion Criteria: 1. Participants with histologically or cytologically conﬁrmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapies with a proven clinical beneﬁt, or who are intolerant to or unwilling to receive these therapies for any reasons. 2. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1. 3. (Part A only) Participants should have 1 of the following tumor types: malignant melanoma, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial c…

Interventions

Drug
S-531011
Administered by intravenous infusion
Drug
Pembrolizumab
Administered by intravenous infusion
Drug
Bevacizumab
Administered by intravenous infusion

Summary

Eligibility

Interventions

Locations (8)