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

NCT05491083 | Recruiting Phase 1

• 1 other identifier: BR01/01/22
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor; Triple Negative Breast Cancer

Keywords

Pembrolizumab; ADG106; Breast Cancer; Triple Negative

Outcome Measures

Primary Outcomes (2)

• Number of participant with treatment related toxicities (Phase Ib)

  Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading Version 5

  3 years

• Objective response rate (ORR) in Phase II

  Complete and partial clinical response will be measured by RECIST 1.1.

  3 years

Study Arms (2)

Phase 1b Pembrolizumab & ADG106

EXPERIMENTAL

Intravenous Pembrolizumab + ADG106 on day 1 of each 3-weekly cycle

Drug: Pembrolizumab & ADG106 (Phase Ib)

Phase 2 Pembrolizumab & ADG106

EXPERIMENTAL

Intravenous Pembrolizumab + ADG106 each 3-weekly cycle

Drug: Pembrolizumab & ADG106 (Phase II)

Interventions

Pembrolizumab & ADG106 (Phase Ib) DRUG

Drug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes

Phase 1b Pembrolizumab & ADG106

Pembrolizumab & ADG106 (Phase II) DRUG

Drug: ADG106 Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. Pembrolizumab Administered as an intravenous infusion over 30 minutes

Phase 2 Pembrolizumab & ADG106

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above of age
• Estimated life expectancy of at least 12 weeks.
• Has recovered from acute toxicities from prior anti-cancer therapies.
• Has a tumor lesion that can be safely biopsied and who is willing to undergo tumor biopsy at baseline before starting study treatment
• Phase Ib
• Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry

You may not qualify if:

• Prior treatment with immunotherapy is allowed.
• Phase II
• Patients with histologically or cytologically confirmed TNBC, defined by expression of estrogen (ER) and progesterone receptors (PR) of \<1% and HER2 IHC score of 0 or 1+ or HER2 IHC score of 2+ but HER2 FISH negative.
• Received at least 1 line but no more than 2 prior lines of systemic therapy in the metastatic setting, including chemotherapy or targeted therapy (e.g., PARP inhibitors).
• Tumor CPS≥1 determined by the DAKO 22C3 assay assessed by local or central laboratory.
• Measurable disease by RECIST 1.1 criteria as determined by local radiological review. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Adequate bone marrow function and organ function within 2 weeks of study treatment.
• Adequate hematologic function defined as:
• Absolute neutrophil count (ANC) - 1.5 x 109/L
• Platelets - 100 x 109/L
• Hemoglobin - 9 x 109/L
• Adequate hepatic function defined as:
• Bilirubin ≤1.5 times the upper limit of normal (ULN)
• ALT or AST ≤ 2.5 times ULN (or ≤5 times ULN with presence of liver metastases)

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Adagene Inc: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (3)

• Caswell-Jin JL, Plevritis SK, Tian L, Cadham CJ, Xu C, Stout NK, Sledge GW, Mandelblatt JS, Kurian AW. Change in Survival in Metastatic Breast Cancer with Treatment Advances: Meta-Analysis and Systematic Review. JNCI Cancer Spectr. 2018 Nov;2(4):pky062. doi: 10.1093/jncics/pky062. Epub 2018 Dec 24.

  PMID: 30627694 BACKGROUND

• Skinner KE, Haiderali A, Huang M, Schwartzberg LS. Real-world effectiveness outcomes in patients diagnosed with metastatic triple-negative breast cancer. Future Oncol. 2021 Mar;17(8):931-941. doi: 10.2217/fon-2020-1021. Epub 2020 Nov 19.

  PMID: 33207944 BACKGROUND

• Fossati R, Confalonieri C, Torri V, Ghislandi E, Penna A, Pistotti V, Tinazzi A, Liberati A. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol. 1998 Oct;16(10):3439-60. doi: 10.1200/JCO.1998.16.10.3439.

  PMID: 9779724 BACKGROUND

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

pembrolizumab; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Soo Chin Lee

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Chin Lee

CONTACT

+65 6908 2222; soo_chin_lee@nuhs.edu.sg

Soo Chin Lee

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Phase Ib: Patients with advanced solid tumors will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 6-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II. * Phase II: Up to a total of 33 patients with advanced triple negative breast cancer will be enrolled.

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 8, 2022
• Study Start: June 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)