A study to evaluate CM24 in combination with nivolumab in adults with solid tumours

Phase 1

• Conditions: Part A- Recurrent and metastatic non-small cell lung cancer (NSCLC), pancreatic cancer, ovarian cancer, papillary thyroid cancer, colorectal adenocarcinoma and melanomaPart B- Recurrent or metastatic immune checkpoint refractory NSCLCPart C- Metastatic pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 24.0Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10052360Term: Colorectal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005016-21-ES
• Lead Sponsor: Famewave Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-30
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Part A
1. Previously treated subjects with recurrent and 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).
2. Adequate safety lab results at Screening and at Baseline (Day 1) for those tests that require repeating at Baseline, including the following:
a. Albumin =3 g/dL;
b. Bilirubin =1.5 times the upper limit of normal (ULN) or <3 times the ULN in the case of Gilbert Syndrome;
c. Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline phosphatase =3 times the ULN;
d. Serum creatinine =1.5xULN and creatinine clearance >40 mL/minute based on the Cockcroft-Gault equation [creatinine clearance in mL/min = (140 – age in years) x body weight (kg)/72 x serum creatinine (mg/dL); multiplied by 0.85 for women];
e. White blood cell (WBC) count =2000/uL; neutrophils =1500/uL; hemoglobin =9 g/dL; platelets =100x103/uL.
3. Brain metastases should be stable following radiosurgery with at least 4 weeks since the end of definitive therapy (i.e., radiotherapy) and without need for steroid therapy as evidenced by imaging performed after completion of any CNS directed therapy demonstrating radiographic stability of CNS lesions.
4. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new tumors since last antitumor therapy.
5. Age =18 years at the time of signing ICF;

Part B
1. Subjects with histologically confirmed metastatic or locally advanced non-small cell lung cancer (NSCLC) with documented progression following anti-PD-1/PD-L1 containing therapy; Subjects must have confirmation of progression of disease that is consistent with iCPD during or within 3 months of prior anti-PD1/PDL1 with either two radiographic scans showing disease progression or documented clinical progression (e.g., worsening of symptoms).
2. Subjects could have had a maximum of 1 prior treatment regimen.
3. Adequate safety lab results at Screening and at Baseline (Day 1) for those tests that require repeating at Baseline, including the following:
a. Albumin =3 g/dL;
b. Bilirubin =1.5 times the upper limit of normal (ULN) or <3 times the ULN in the case of Gilbert Syndrome;
c. Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline phosphatase =3 times the ULN;
d. Serum creatinine =1.5xULN and Creatinine clearance >40 mL/minute based on the Cockcroft-Gault equation [creatinine clearance in mL/min = (140 – age in years) x body weight (kg)/72 x serum creatinine (mg/dL); multiplied by 0.85 for women];
e. White blood cell (WBC) count =2000/uL; neutrophils =1500/uL; hemoglobin =9 g/dL; platelets =100x103/uL.
4. Brain metastases should be stable following radiosurgery with at least 4 weeks since the end of definitive therapy (i.e., radiotherapy) and without need for steroid therapy as evidenced by imaging performed after completion of any CNS directed therapy demonstrating radiographic stability of CNS lesions.
5. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new tumors since last antitumor therapy.

Part C
1. Subjects with histologically confirmed metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines; Subjects with islet cell neoplasms are excluded.
2. Subjects with a maximum of 1 prior treatment regimen for metastatic disease excluding nab-paclitaxel containing regimens and up to 8 weeks fro

Exclusion Criteria

Part A
1. History of weight loss >10% over the 2 months prior to Screening.
2. Received more than two prior systemic regimens for the metastatic disease.
3. Unresolved AEs > Grade 1 from prior anticancer therapy. Exempted are effects that are often non-reversible or require a prolonged time for reversal (e.g., alopecia, hypothyroidism, neuropathy).
4. Concurrent malignancy requiring treatment. Participants with a previously treated malignancy are eligible if treatment was completed at least 2 years before study start and the patient has no evidence of disease. Participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment or with a history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
5. Active, untreated central nervous system (CNS) metastases.
6. Subjects previously treated with an anti PD-1/PD-L1 targeting agent with history immune mediated toxicity of = Grade 3, treatment of their toxicity with systemic corticosteroids, or any hypersensitivity to PD-1/PDL-1 targeting agents or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
7. Severely immunocompromised as defined by white blood cell (WBC) count <2000/mm3 and/or CD4+ lymphocyte count =200/mm3.
8. History of allergy or hypersensitivity to any of the study treatment components
9. Major surgery within 4 weeks of study administration.
10. Participants who have received a live / attenuated vaccine within 30 days of first treatment;
11. Subjects with serious or uncontrolled medical disorders other than the metastatic disease;
12. Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study.

Parts B and C
1. History of weight loss >10% over the 2 months prior to Screening;
2. Received more than 1 prior systemic regimens for the advanced/recurrent and/or metastatic disease;
3. Unresolved AEs > Grade 1 from prior anticancer therapy. Exempted are effects that are often non-reversible or require a prolonged time for reversal (e.g., alopecia, hypothyroidism, neuropathy).
4. Concurrent malignancy requiring treatment. Participants with a previously treated malignancy are eligible if treatment was completed at least 2 years before study start and the patient has no evidence of disease. Participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment or with a history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
5. Active and/or untreated central nervous system (CNS) metastases including leptomeningeal metastases;
6. Severely immunocompromised as defined by white blood cell (WBC) count <2000/mm3 and/or CD4+ lymphocyte count =200/mm3.
7. History of allergy or hypersensitivity to any of the study treatment components; subjects previously treated with an anti PD-1/PD-L1 targeting agent with history of immune-mediated toxicity of = Grade 3 treatment of their toxicity with systemic corticosteroids, or any hypersensitivity to PD-1/PD-L1 targeting agents or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
8. Major surgery within 4 weeks of study administration;
9. Participants who have received a l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified