NCT02538627

A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients

Terminated Phase 1 Last updated 31 August 2017

What this trial tests

Phase 1 trial testing MM-151 in Colorectal Cancer in 5 participants. Terminated before completion.

Timeline

1 August 2015

Primary endpoint
5 October 2016

5 October 2016

Quick facts

Lead sponsor	Merrimack Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 August 2015
Primary completion	5 October 2016
Estimated completion	5 October 2016
Sites	5 locations across United States

Drugs / interventions tested

• MM-151 — full drug profile →
• MM-121 — full drug profile →
• MM-141 — full drug profile →
• trametinib (trametinib) — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →

Sponsor

Merrimack Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers
  Time frame: 1.5 years

Sponsor's own description

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
   Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
2. Thirty Years of HER3: From Basic Biology to Therapeutic Interventions.
   Haikala HM, Jänne PA. · · 2021 · cited 84× · PMID 33608318 · DOI 10.1158/1078-0432.ccr-20-4465
3. HER3 in cancer: from the bench to the bedside.
   Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2022 · cited 71× · PMID 36271429 · DOI 10.1186/s13046-022-02515-x
4. Emerging therapeutic agents for lung cancer.
   Dholaria B, Hammond W, Shreders A, Lou Y. · · 2016 · cited 66× · PMID 27938382 · DOI 10.1186/s13045-016-0365-z
5. Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.
   Sun Y, Yu X, Wang X, Yuan K, et al · · 2023 · cited 62× · PMID 37719370 · DOI 10.1016/j.apsb.2023.05.023
6. A comprehensive review of heregulins, HER3, and HER4 as potential therapeutic targets in cancer.
   Mota JM, Collier KA, Barros Costa RL, Taxter T, et al · · 2017 · cited 52× · PMID 29179520 · DOI 10.18632/oncotarget.18467
7. Bispecific Antibodies: A Smart Arsenal for Cancer Immunotherapies.
   You G, Won J, Lee Y, Moon D, et al · · 2021 · cited 39× · PMID 34358141 · DOI 10.3390/vaccines9070724
8. Targeting HER3 using mono- and bispecific antibodies or alternative scaffolds.
   Malm M, Frejd FY, Ståhl S, Löfblom J. · · 2016 · cited 38× · PMID 27532938 · DOI 10.1080/19420862.2016.1212147