To assess safety and efficacy of PNB028 in colon or pancreatic cancer patients.

Phase 1

• Conditions: Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: C259- Malignant neoplasm of pancreas, unspecified

• Registration Number: CTRI/2024/01/062125
• Lead Sponsor: PNB Vesper Life Science Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Colon cancer patients who have failed to 2nd line of chemotherapy or pancreatic cancer patients who have failed to 1st line of chemotherapy. Study drug can also be used as 1st line or 2nd line in colon cancer and as 1st line in pancreatic cancer if other lines of treatment are not feasible for any reason.

2. Eastern Cooperative Oncology Group (ECOG) performance status Less than or equal 2.

3. Patients with life expectancy of at least 12-24 months in colon cancer and =4 months in pancreatic cancer.

4. The serum pregnancy test at screening and urine pregnancy test before dosing on day 01 must be negative for female patients of childbearing potential.

5. Physical examination, 12-lead electrocardiogram (ECG) and vital signs without any clinically significant findings as per discretion of the investigator.

6.Clinical laboratory values within the acceptable range, unless deemed clinically not significant by the investigator.

7.Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements as evidenced by signing the Informed Consent Form (ICF).

Exclusion Criteria

1. Patients with known brain metastasis.

2. Patients with any other malignancy other than colon cancer or pancreatic cancer.

3.History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic (other than colon and pancreatic cancer), pulmonary, immunologic, musculoskeletal, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.

4.A history of allergic response(s) to cholecystokinin receptor antagonist.

5.History of chemotherapy or radiotherapy within 2 weeks before screening.

6.History of biological therapy within 2 weeks before screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified