Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev Wainberg (ucla)

Description

Summary

This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).

Official Title

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors

Details

The study consists of 3 parts: dose escalation (Part 1), dose expansion (Part 2), and dose exploration (Part 3). Part 1 will evaluate dose escalation of durvalumab in combination with monalizumab in adult participants with select advanced solid tumor malignancies. Part 2 will evaluate further the identified dose of durvalumab in combination with monalizumab from Part 1 in adult participants with select advanced solid tumor malignancies. Part 3 will evaluate dose exploration of durvalumab in combination with monalizumab and standard of care systemic therapy with or without biological agent, and monalizumab in combination with biological agent in adult participants with CRC.

Keywords

Advanced Solid Tumors, Colorectal, colon, CRC, solid tumors, check point inhibitors, immunotherapy, metastatic, Neoplasms, Bevacizumab, Cetuximab, Durvalumab, Monalizumab, mFOLFOX6, Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W

Eligibility

You can join if…

Open to people ages 18-99

  1. Participants must have histologic documentation of advanced recurrent or metastatic cancer.
  2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
  3. Participants must have at least one lesion that is measurable by RECIST v1.1
  4. Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.

You CAN'T join if...

  1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
  2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
  3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
  4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.

Locations

  • Research Site
    Santa Monica California 90404 United States
  • Research Site
    La Jolla California 92093 United States
  • Research Site
    Sacramento California 95817 United States
  • Research Site
    Los Angeles California 90089 United States
  • Research Site
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Zev Wainberg (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 143 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
Links
redacted CSP redacted SAP redacted CSR Synopsis
ID
NCT02671435
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 383 people participating
Last Updated