Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer
ComPACT
A Phase 1b Followed by Phase II Expansion Trial of Combination of Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (ComPACT)
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
recruiting
Estimated enrollment
51 participants
Study completion date
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations
1 countries · 1 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
July 18, 2022
Actual (reported)
First Posted
August 8, 2022
Actual (reported)
Study Start
June 12, 2023
Actual (reported)
Primary Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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)
+29 more criteria
Contact the study team to confirm eligibility.
Industrycollaborator
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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