Actively Recruiting
Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer
Led by National University Hospital, Singapore · Updated on 2025-07-25
51
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
A
Adagene Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- Estimated life expectancy of at least 12 weeks
- Recovered from acute side effects of prior cancer treatments
- Have a tumor lesion that can be safely biopsied and willing to undergo biopsy before treatment
- Phase Ib: Histologically or cytologically confirmed advanced or metastatic solid tumors with evidence of disease progression
- No limit on prior treatments for Phase Ib patients
- Prior immunotherapy allowed in Phase Ib
- Phase II: Histologically or cytologically confirmed triple negative breast cancer with ER and PR expression <1% and HER2 negative
- Received 1 to 2 prior systemic therapies in metastatic setting, including chemotherapy or targeted therapy
- Tumor PD-L1 CPS score ≥1 by DAKO 22C3 assay
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate bone marrow, liver, kidney, and coagulation function within 2 weeks before treatment
- Use of approved contraception for patients with reproductive potential during and after study as specified
- Signed informed consent and ability to comply with study procedures
You will not qualify if you...
- Treatment with any investigational drug within 30 days prior to study
- Prior immune checkpoint inhibitor treatment in Phase II (allowed in Phase Ib)
- Receiving any other tumor therapy during study
- Major surgery within 28 days before study drug
- Radiotherapy within 2 weeks before study start unless palliative and with appropriate recovery
- Active infections requiring systemic therapy
- Serious medical conditions compromising safety or study completion
- Severe hypersensitivity to pembrolizumab or its ingredients
- Active or recent autoimmune disease requiring systemic treatment in past 2 years
- Recent systemic corticosteroid or immunosuppressive treatment within 14 days before enrollment
- Live vaccine within 30 days before first dose
- History or presence of pneumonitis or interstitial lung disease requiring steroids
- Known HIV/AIDS infection
- Active hepatitis B or C infection as defined
- Pregnant, breastfeeding, or planning to conceive/father children during study and follow-up
- Second primary malignancy detectable at study entry (with some exceptions)
- Active brain metastases or carcinomatous meningitis unless stable and off steroids
- Significant neurological or mental disorders
- History of allogeneic tissue or organ transplant
- Unable to comply with study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
S
Soo Chin Lee
CONTACT
S
Soo Chin Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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