Clinical trial · Interventional
Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)
A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated early due to business reasons.
Summary
Brief summary (as posted)
This was a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the treatment of advanced malignancies. The study included an initial Dose Evaluation phase (Part A) to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating Dose Limiting Toxicities (DLTs) of four dose combinations of MK-1966 and SD-101. Following determination of the MTD/MAD, approximately 20 participants each were to be enrolled in two expansion cohorts (Parts B or C) to confirm/refine the MTD/MAD. The study was terminated by the Sponsor before enrollment into Part A concluded and before enrollment into Parts B and C began.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Advanced | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-1966 | Biological | — | UNRESOLVED |
| SD-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Dose A MK-1966 + Dose A SD-101
- description
- Participants received a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
- interventionNames
- Biological: MK-1966
- Drug: SD-101
- type
- EXPERIMENTAL
- label
- Dose A MK-1966 + Dose B SD-101
- description
- Participants received a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
- interventionNames
- Biological: MK-1966
- Drug: SD-101
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced malignancy that has progressed after standard-of-care therapy/treatments and there is no available therapy likely to convey clinical benefit * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Has a life expectancy ≥ 6 months * Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test at screening and again within 72 hours prior to receiving the first dose of study therapy) * Female and male participants of reproductive potential must agree to use adequate contraception during the course of the study through 120 days after study the last dose of study therapy * Has ability to submit archived or fresh tumor sample during the screening period Exclusion Criteria: * Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier * Has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of study start * Is expected to require any other form of antineoplastic therapy while on study * Is on chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication * Has a history of a malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has an active infection requiring therapy * Has active, current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids * Has had a prior stem cell or bone marrow transplant * Is positive for Human Immunodeficiency Virus (HIV) and/or Hepatitis B or C * Has known psychiatric disorder that would interfere with fulfilling the requirements of the study * Is a regular user of any illicit drugs or had a recent history of substance abuse * Has symptomatic ascites or pleural effusion * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study * Has clinically significant heart disease that affects normal activities * Has had major surgery (requiring at least a 3 day hospital stay) in the past 28 days * Has received a live vaccine within 30 days prior to first dose of study therapy
References
Publications (0)
Data not yet available