Modakafusp Alfa (TAK-573) and Pembrolizumab in Advanced or Metastatic Solid Tumors

Summary

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an investigational drug called modakafusp alfa in combination with pembrolizumab in patients with metastatic cutaneous melanoma that is unresectable (cannot be removed with surgery) /advanced. A safe dose of modakafusp alfa has been established and is now being studied in combination with pembrolizumab for safety, tolerability, and effectiveness. This combination is being studied in advanced melanoma that has not previously responded to treatment, as well as in patients who have not received any treatment for advanced/unresectable melanoma of the skin. Modakafusp alfa is a targeted drug therapy that is capable of binding to two proteins found on the surface of cells, which is expected to stimulate the immune response against tumors. Pembrolizumab is an immunotherapy which has been approved by the U.S. Food and Drug Administration for certain cancers, including individuals with unresectable or metastatic melanoma.


Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • For both the dose escalation and expansion cohort phases of the study, eligible participants must have histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors.
  • Measurable disease per RECIST v1.1. At least 1 target lesion amenable for biopsy is required for enrollment in phase 1b. A minimum of 1 target lesion for response assessment is required for enrollment in phase 2. A separate lesion amenable for biopsy is required for enrollment in phase 2 for cohorts I and II post futility analysis and for all participants (safety lead-in and expansion) with subgroup III melanoma.
  • Phase 1b Dose Escalation: Participants with histologically confirmed advanced locally (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors.
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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

Full Title

TAK-573-1001: An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-573 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Metastatic Solid Tumors

Details
Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Kristopher Wentzel, Michelle Offner, Omid Hamid, Rodolfo Gutierrez, Vi K. Chiu

Age Group

Adult

Phase

I/II

IRB Number

STUDY00001545

ClinicalTrials.gov ID

NCT04157517

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Age Group

Adult

Phase

I/II

IRB Number

TAK-573-1001

ClinicalTrials.gov ID

NCT04157517

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Want to join the study or
learn more?