Pembrolizumab & ADG106 in Advanced Solid Cancers & Triple Negative Breast

Status Recruiting

Clinical Trial Summary

This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.

Clinical Trial Description

2.1 Hypothesis - Combination of ADG106 and pembrolizumab is safe with a reasonable toxicity profile. - Combination of ADG106 and pembrolizumab is effective and can improve outcomes in patients with advanced TNBC. - Predictive biomarkers may help select patients most likely to benefit from combination therapy. 2.2 Primary Objectives Phase Ib - Evaluate the safety and tolerability of combination of ADG106 with pembrolizumab in patients with advanced solid tumors. - Determine recommended phase II dose (RP2D) of ADG106 in combination with pembrolizumab. Phase II • Evaluate the clinical efficacy of ADG106 plus pembrolizumab in terms of ORR in patient with advanced TNBC with CPS ≥1 2.3 Secondary Objectives Phase Ib • Evaluate preliminary anti-tumor effect of combination of ADG106 with pembrolizumab in terms of ORR, disease control rate (DCR), PFS and OS in patients with treatment refractory solid tumors Phase II - Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of DCR, PFS and OS in patients with advanced TNBC with CPS≥1 - Evaluate clinical efficacy of ADG106 plus pembrolizumab in terms of ORR, DCR, PFS and OS in patients with advanced TNBC with CPS≥10 2.4 Exploratory Objectives - Evaluate predictive biomarkers (e.g., tumor PD-L1 CPS score) for response to ADG106 plus pembrolizumab. - Evaluate changes in tumor microenvironment with combination of ADG106 plus pembrolizumab. - Evaluate changes in tumor genomic expression profile with combination of ADG106 plus pembrolizumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05491083
Study type	Interventional
Source	National University Hospital, Singapore
Contact	Soo Chin Lee
Phone	+65 6908 2222
Email	soo_chin_lee@nuhs.edu.sg
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	June 12, 2023
Completion date	December 31, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer — ComPACT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms