A Study Of CM24 In Combination With Nivolumab In Adults With Advanced Solid Tumors

Study Overview

A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors

This is an open-label, multicenter, multi-dose escalation and dose expansion study in subjects with selected advanced solid tumors (Part A) and advanced metastatic pancreatic cancer (Parts C & D) to evaluate the safety and tolerability of CM-24 in combination with nivolumab. In Part C of the study gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV will be administered subsequent to CM24 and nivolumab. CM24, nivolumab and gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV are administered intravenously.

N/A

Solid Tumor
Non Small Cell Lung Cancer
Pancreatic Cancer
Ovarian Cancer
Papillary Thyroid Cancer
Melanoma
Colorectal Adenocarcinoma

DRUG: CM-24 and Nivolumab - Dose Escalation
DRUG: CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion
DRUG: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion
DRUG: Nivolumab, Nab paclitaxel and Gemcitabine - Expansion
DRUG: Nivolumab and Nal-IRI/5-FU/LV - Expansion

FW-2020-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-01-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-23
First Submitted that Met QC Criteria 2021-01-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-27
First Posted (ACTUAL) 2021-02-01	Results First Posted N/A	Last Verified 2024-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A- Dose escalation of CM24 in combination with nivolumab	DRUG: CM-24 and Nivolumab - Dose Escalation Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors
EXPERIMENTAL: Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine	DRUG: CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
EXPERIMENTAL: Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV	DRUG: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
EXPERIMENTAL: Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine	DRUG: CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
EXPERIMENTAL: Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV	DRUG: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
ACTIVE_COMPARATOR: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine	DRUG: Nivolumab, Nab paclitaxel and Gemcitabine - Expansion Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
ACTIVE_COMPARATOR: Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV	DRUG: Nivolumab and Nal-IRI/5-FU/LV - Expansion Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer

Primary Outcome Measures	Measure Description	Time Frame
Part A: Incidence of treatment emergent adverse events	Incidence of treatment emergent adverse events with CM-24 and nivolumab in adults with selected recurrent or metastatic solid tumors	Up to 24 months
Part C: Safety and tolerability	Incidence of treatment emergent adverse events with CM-24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV in adults with advanced metastatic pancreatic cancer	Up to 24 months
Part D: Overall survival	This is an exploratory randomized sub-study with the objective of estimating the efficacy of CM24 and nivolumab with chemotherapy (Nal-IRI/5-FU/LV or gemcitabine/ nab-paclitaxel) and chemotherapy only (Nal- IRI/5-FU/LV or gemcitabine/nab-paclitaxel) as measured by overall survival.	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
Maximum serum concentration [Cmax]	Maximum serum concentration [Cmax] of CM24	Up to 24 months
Time of maximum concentration [Tmax]	Time of maximum concentration [Tmax] of CM24	Up to 24 months
Area under the serum concentration curve [AUC]	Area under the serum concentration curve [AUC] of CM24	Up to 24 months
Half life	Half life of CM24	Up to 24 months
Drug clearance	Drug clearance of CM24	Up to 24 months
Volume of distribution	Volume of distribution of CM24	Up to 24 months
Serum ADA parameters	Serum ADA parameters of CM24 as measured by percentage of patients who are positive for the presence of anti-drug antibodies	Up to 24 months
Objective Response Rate when CM24 is used in combination with nivolumab		Up to 24 months
Disease Control Rate when CM24 is used in combination with nivolumab		Up to 24 months
Median Duration of Response when CM24 is used in combination with nivolumab		Up to 24 months
Median Time to Response when CM24 is used in combination with nivolumab		Up to 24 months
Progression Free Survival when CM24 is used in combination with nivolumab		Up to 48 months
Overall Survival when CM24 is used in combination with nivolumab		Up to 48 months
Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the maximum plasma concentration [Cmax]		Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the average area under the concentration curve [AUC]		Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the median area under the concentration curve [AUC]		Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the maximum plasma concentration [Cmax]		Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the average area under the concentration curve [AUC]		Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the median area under the concentration curve [AUC]		Up to 24 months
Disease Control Rate when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV		Up to 24 months
Duration of Response when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV		Up to 24 months
Time to Response when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV		Up to 24 months
Progression Free Survival when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV		Up to 48 months
Overall Survival when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV		Up to 48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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. 3. 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. 4. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new tumors since last antitumor therapy; 5. ECOG performance status score of 0 or 1; 6. Adequate safety lab results; 7. Stable brain metastases; 8. 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.

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; 12. Radiation within two weeks prior to the first study treatment; 13. Treatment with another investigational therapy within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer; 14. 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; 15. Pregnant or lactating women.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Bristol-Myers Squibb

Investigators

STUDY_DIRECTOR: Michael Schickler, PhD, Famewave Ltd.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record