Health Condition 1: C81- Hodgkin lymphoma Health Condition 2: C34- Malignant neoplasm of bronchus andlung Health Condition 3: C15-C26- Malignant neoplasms of digestive organs Health Condition 4: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: CA 170: CA-170 will be administered
once daily in continuous,
consecutive 21-day treatment
cycles. Patients will take each dose of CA-170 orally with water at approximately the same tim
Sponsors
Aurigene Discovery Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females >= 18 years of age; 2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 (See Appendix A); In brief, this criterion requires that the patient either be fully active or at least should be able to carry out work of a light or sedentary nature. 3. Acceptable bone marrow and organ function at screening as described below: a. ANC >= 1500/μL (without WBC growth factor support) b. Platelet count >= 75,000/μL; c. Hemoglobin >= 9 g/dL d. Total Bilirubin e. AST (SGOT) f. ALT (SGPT) g. Serum creatinine = 40 mL/min according to Cockcroft-Gault formula. 4. Ability to swallow and retain oral medications; 5. Negative serum pregnancy test in women of childbearing potential (WOCBP); 6. Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) for contraception (as defined in Section 8.3.4) for the duration of the study, i.e. through 28-day safety follow up visit; 7. Willing and able to provide written informed consent and comply with the requirements of the trial; 8. Evidence of measurable disease per RECIST, v1.1 or Revised Response Criteria for Malignant Lymphoma. Measurable disease is defined as a lesion that can be accurately measured in at least 1 dimension in solid tumors or 2 dimensions in Hodgkin Lymphoma with a minimum size of 10 mm (longest diameter to be recorded); 9. Trial participants with accessible tumors must agree to pre-treatment biopsies for biomarkers including PD-L1 testing, as required by the protocol, unless the biopsy is medically contraindicated or unsafe or the tumor is not accessible. (Note: PD-L1 status is not a requirement for study enrollment.) Patients must have archival specimen if a new pre-treatment biopsy is not being done because of inaccessibility of tumor, contraindication for biopsy or safety issues. 10. Patients with one of the following histologically confirmed advanced tumor types who have received 1-3 lines of prior therapy. 10a. Non-Squamous Non-Small Cell Lung Cancer (Non-Squamous NSCLC) 10b. Squamous Non-Small Cell Lung Cancer (Squamous NSCLC) 10c. Squamous Cell Cancer of Head & Neck (SCCHN) 10d. Microsatellite Instability-High (MSI-High) or Mismatch Repair Deficient (dMMR) Tumours (e.g. Colorectal Carcinoma, Gastric Carcinoma, Endometrial Carcinoma, Cholangiocarcinoma, etc.) 10e. Classical Hodgkin Lymphoma Patients in 10d, in general, should already be known to have MSI-H / dMMR status at the time of screening. However, patients with unknown MSI status may also be screened (at designated central lab) by IHC for the absence of the protein products (MLH1, MSH2, MSH6 and PMS2) of the respective mismatch repair (MMR) genes. Those with known MSI-H / dMMR status by a previously done IHC or PCR will also be confirmed at designated central lab by IHC for the absence of at least one of the protein products (MLH1, MSH2, MSH6 and PMS2) before enrolment. Confirmation by central lab review is necessary before patient enrolment. The list of tumors with MSI-H / dMMR biomarker status is expanding and all solid tumors with literature support will be a
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Overall Response Rate (ORR) by RECIST 1.1 in each solid tumor cohort and by Revised Response Criteria for Malignant Lymphoma in Classical Hodgkin Lymphoma cohort (Tumor Assessment Through the End of Cycle 4).Timepoint: Through Cycle 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR,Time to Progression, Progression Free Survival (PFS) and Overall Survival (OS) in each tumor typeTimepoint: Screening, Cycle 1, Cycle 2, cycle 4, cycle 6 and every three weeks then after wherever applicable. | — |
Countries
India
Contacts
Public ContactAbhijit Sharma
Aurigene Discovery Technologies limited
Outcome results
None listed