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Closed (no longer recruiting)Last updated: 2 February 2024

INNATE: This phase I/II trial is evaluating the effectiveness and appropriate dosing for using a combination of two targeted therapies (Durvalumab and Monalizumab) to treat selected advanced solid tumours. In addition, this trial will assess the effectiveness of using the current standard of care therapy, with or without biological agent, in combination with durvalumab and monalizumab or monualizumab alone with biological agent to treat patients with recurrent or metastatic colorectal cancer.A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors

Clinical summary

Summary

Patients eligible to participate in this study will receive some combination of Durvalumab, Monalizumab and/or Cetuximab.

Conditions

This trial is treating patients with advanced solid tumours.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

INNATE

More information

Trial Identifiers

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Trial sponsor

MedImmune, LLC

Scientific Title

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

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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