Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types

Part of paid clinical trials in Los Angeles, California.

Sponsor
Molecular Templates, Inc.
Study ID
NCT06034860
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MT-8421 — DRUG
    Experimental treatment with MT-8421
  • Nivolumab — DRUG
    480 mg nivolumab administered on Day 1 of each cycle starting with Cycle 2 for all combination dose escalation and dose expansion cohorts

Study Details

This is a Phase 1, open-label, dose escalation and expansion study of MT-8421 (an Engineered Toxin Body (ETB)) as monotherapy and in combination with nivolumab in patients with selected advanced solid cancer types. MT-8421 is an investigational drug that specifically targets and depletes cytotoxic T-lymphocytes-associated protein 4 (CTLA-4) expressing cells in an effort to directly dismantle the tumor microenvironment for the treatment of patients with advanced solid tumors.

Key Dates

Start date
Nov 1, 2023
Status verified
Oct 2024
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A- Dose Escalation Monotherapy
    Part A- Dose escalation of MT-8421 monotherapy in patients with selected advanced solid tumors. The assigned dose level of MT-8421 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e. on day 1, day 8, day 15, and day 22 of each 28-day cycle).
  • Experimental: Part A- Dose Escalation Combination Therapy
    Part A- Dose escalation of MT-8421 in combination with nivolumab in patients with selected advanced solid tumors. The assigned dose level of MT-8421 will be given as an intravenous (IV) infusion over about 30 minutes prior to the infusion of 480 mg nivolumab. MT-8421 will be given on the same day every week (i.e. on day 1, day 8, day 15, and day 22 of each 28-day cycle). Nivolumab will be given on the first day of each cycle beginning at cycle 2.
  • Experimental: Part B Dose Expansion Monotherapy
    Part B- Dose expansion of MT-8421 monotherapy in patients with selected advanced solid tumors. Part B monotherapy will include two expansion groups: Group B1 (NSCLC) and group B2 (HCC). The assigned dose level of MT-8421 determined in Part A will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e. on day 1, day 8, day 15, and day 22 of each 28-day cycle).
  • Experimental: Part B Dose Expansion Combination
    Part B- Dose escalation of MT-8421 in combination with nivolumab in patients with selected advanced solid tumors. Part B combination therapy will include two expansion groups: Group B3 (Melanoma) and Group B4 (RCC). The assigned dose level of MT-8421 determined in Part A will be given as an intravenous (IV) infusion over about 30 minutes prior to the infusion of 480 mg nivolumab. MT-8421 will be given on the same day every week (i.e. on day 1, day 8, day 15, and day 22 of each 28-day cycle). Nivolumab will be given on the first day of each cycle beginning at cycle 2.

Primary Outcome Measure

Number of participants with Adverse Events [ Time Frame: 28 day cycle ]

Locations (5)

FacilityCityStateZIPSite coordinators
The Angeles ClinicLos AngelesCalifornia90025-
Horizon Oncology Research, LLCLafayetteIndiana47905-
Washington University in St. LouisSt LouisMissouri63110-
Weill Cornell MedicineNew YorkNew York10065-
NEXT OncologyFairfaxVirginia22031-

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By research site
The Angeles Clinic· Los Angeles, CAHorizon Oncology Research, LLC· Lafayette, INWashington University in St. Louis· St Louis, MOWeill Cornell Medicine· New York, NYNEXT Oncology· Fairfax, VA

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