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Clinical trial of dose escalation and dose escalation of ozuriftamab vedotin in combination with nivolumab in patients with advanced stage solid tumors.
THE OBJECTIVE OF THIS STUDY IS TO DETERMINE THE SAFETY AND EFFICACY OF AN EXPERIMENTAL DRUG CALLED OZURIFTAMAB VEDOTIN (BA3021) IN DIFFERENT MALIGNANCIES EXPRESSING THE ROR2 PROTEIN, BOTH ALONE AND IN COMBINATION WITH NIVOLUMAB (AN APPROVED DRUG). THE OBJECTIVES ARE AS FOLLOWS: EVALUATE HOW OZURIFTAMAB VEDOTIN, BOTH ALONE AND IN COMBINATION WITH NIVOLUMAB, AFFECTS TUMOR GROWTH OR FORMATION; EVALUATE THE SAFETY OF OZURIFTAMAB VEDOTIN, BOTH ALONE AND IN COMBINATION WITH NIVOLUMAB, IN PATIENTS WITH ADVANCED-STAGE NSCLC AND MELANOMA; UNDERSTAND HOW THE DRUG OZURIFTAMAB VEDOTIN IS ABSORBED AND PROCESSED BY THE BODY (CALLED PHARMACOKINETICS [PK]) BY MEASURING THE AMOUNT OF STUDY DRUG IN THE BLOOD BEFORE, DURING, AND AFTER RECEIVING THE DRUG; UNDERSTAND WHETHER OZURIFTAMAB VEDOTIN, EITHER ALONE OR IN COMBINATION WITH NIVOLUMAB, CAUSES AN IMMUNE SYSTEM RESPONSE THAT IS ASSOCIATED WITH THE PRODUCTION OF ANTIBODIES THAT MAY PREVENT THE STUDY DRUG FROM WORKING OR INCREASE THE RISK OF SIDE EFFECTS.
- PHASE 1/2 DOSE ESCALATION AND DOSE ESCALATION STUDY OF OZURIFTAMAB VEDOTIN (BA3021) IN MONOTHERAPY AND IN COMBINATION WITH NIVOLUMAB IN PATIENTS WITH ADVANCED STAGE SOLID TUMORS. IMMUNOTHERAPY
- Code EudraCT: 2022-000137-17
- Protocol number: BA3021-001
- Promoter: BioAtla Inc,
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