A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in combination with nivolumab in adults with advanced solid tumors

Cancer Categories

Gastrointestinal (GI),Lung

Karmanos Trial ID

2021-039

NCT ID

NCT04731467

Age Group

Adult

Scope

National

Phase

Phase I/II

Principal Investigator

Mohammed Najeeb
Al Hallak, M.D., MS
Oncology - Medical View Profile

Objective:

Part A - Dose Escalation Phase of CM24 in Combination with Nivolumab

Primary Objectives

To assess the safety, tolerability and the maximum tolerated dose (MTD) of CM24 in combination with 480mg nivolumab in adults with selected recurrent or metastatic solid tumors.
Determine the recommended Phase 2 dose level (RP2D) of CM24 in combination with nivolumab

Part B - Expansion Phase of CM24 in combination with nivolumab in patients with NSCLC

Primary Objective

To assess the efficacy of the recommended phase 2 dose (RP2D) of CM24 in combination with nivolumab in adults with immune-checkpoint refractory recurrent or metastatic NSCLC based on Objective Response Rate (ORR).

Part C - Expansion Phase of CM24 in combination with nivolumab and nab-paclitaxel in patients with pancreatic adenocarcinoma

Primary Objective

To assess the efficacy of CM24 in combination with nivolumab and nab-paclitaxel in adults with metastatic pancreatic cancer based on Objective Response Rate.

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Eligibility

Inclusion Criteria:

Part A: Previously treated subjects with recurrent and/or metastatic NSCLC, pancreatic cancer, ovarian cancer, papillary thyroid cancer, colorectal adenocarcinoma and melanoma with documented progression/intolerance following at least one previous therapy (and not more than 2 previous regimens); Part C: Subjects with histologically confirmed advanced metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines; Subjects with islet cell neoplasms are excluded; subjects with a maximum of 1 prior treatment regimen for metastatic disease excluding: nab-paclitaxel containing regimens and up to 8 weeks from last chemotherapy treatment (Arm #1); fluoropyrimidine or irinotecan containing regimens and up to 8 weeks from last chemotherapy treatment (Arm #2).

Part D: Subjects with histologically confirmed advanced metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines; Subjects with islet cell neoplasms are excluded.

Parts C, D: Subjects who have progressed on or after standard of care chemotherapy with a maximum of 1 prior treatment regimen for advanced metastatic disease:

Subjects enrolled in arm with gemcitabine/nab-paclitaxel combination should have received a fluoropyrimidine and/or irinotecan containing regimen in the first line of treatment; Prior gemcitabine containing regimen may be allowed only if completed at least 6 months prior to study enrollment.
Arm #2: Subjects enrolled in arm with Nal-IRI/5FU/LV combination should have received a gemcitabine and/or nab-paclitaxel containing regimen in the first line of treatment; Prior irinotecan and/or fluoropyrimidine containing regimens may be allowed only if completed at least 6 months prior to study enrollment.

Part A: Availability of an archival tumor sample prior to first treatment. Parts C, D: Fresh tumor biopsy must be obtained within 3 months prior to enrollment and after the last systemic treatment was completed.
Must have at least 1 measurable lesion per RECIST1.1 with progressing or new tumors since last antitumor therapy;
ECOG performance status score of 0 or 1;
Adequate safety lab results;
Stable brain metastases;
WCBP (Women of Childbearing Potential) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test, WCBP must agree to abstain from sex or use an adequate method of contraception, males must abstain from sex with WCBP or use an adequate method of contraception.

Exclusion Criteria:

Part A: Received more than two prior systemic regimens for the metastatic disease Parts C and D: Received more than 1 prior systemic regimens for the advanced metastatic disease
Part A: History of weight loss >10% over the 2 months prior to Screening;
Unresolved AEs > Grade 1 from prior anticancer therapy.
Concurrent malignancy requiring treatment;
Active, untreated central nervous system (CNS) metastases;
Subjects previously treated with an anti PD-1/PD-L1 targeting agent with history immune mediated toxicity;
Severely immunocompromised;
History of allergy or hypersensitivity to any of the study treatment components;
Major surgery within 4 weeks of study administration;
Received a live / attenuated vaccine within 30 days of first treatment
Clinically relevant serious co-morbid medical conditions including, but not limited to:

Active infection;
Recent (within six months of Screening) cardiac disease, myocardial infarction, or severe or unstable angina;
History of serious arrhythmia;
Chronic obstructive or chronic restrictive pulmonary disease, pulmonary hypertension history of or active interstitial lung disease or pneumonitis;
Prior organ allograft;
Subjects with active, known or suspected autoimmune disease;
History of active or latent tuberculosis infection;
Positive test for HIV, HBV, or HCV;

Radiation within two weeks prior to the first study treatment;
Treatment with another investigational therapy within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to treatment;
Pregnant or lactating women.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

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