NCT05869240

BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors

A Phase I/II, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPB-101 in Patients With Advanced Malignant Solid Tumors.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, Phase I/II clinical study of BPB-101 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of BPB-101.

Detailed description

This trial consist of 3 parts: dose escalation(phase Ia), dose expansion(phase Ib) and clinical expansion(phase II) part. The current trial is composed of dose escalation with accelerated titration and "3 + 3" cohort design (phase Ia), for which 1 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLT), followed by a consecutive parallel-group expansion in selected dose levels (phase Ib) and selected solid tumor indications (phase II). Participants enrolled in Phase 2 will receive the Recommend Phase 2 Dose (RP2D) of BPB-101 (determined by phase Ia dose escalation and phase Ib dose expansion) until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BPB-101	Subjects will receive an intravenous infusion of BPB-101 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-08-02
• Completion: 2025-09-01
• First posted: 2023-05-22
• Last updated: 2023-06-06

Locations

4 sites across 1 country: China