Study identifier:D7980C00001
ClinicalTrials.gov identifier:NCT03530397
EudraCT identifier:2018-003075-35
CTIS identifier:N/A
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects with Advanced Solid Tumors.
Selected advanced solid tumors
Phase 1
No
Pemetrexed, Carboplatin, Paclitaxel or Nab-Paclitaxel
All
401
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by MedImmune, LLC
MedImmune, LLC
-
The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
This is a phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability, and efficacy, pharmacokinetics and Immunogenicity of MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.
Location
Location
Melbourne, Australia, 3004
Location
Randwick, Australia, 2031
Location
Seoul, Republic of Korea, 06351
Location
Seoul, Republic of Korea, 05505
Location
Seoul, Republic of Korea, 03722
Location
Seoul, Republic of Korea, 03080
Location
Melbourne, Australia, 3000
Location
Taichung, Taiwan, Province of China, 40705
Arms | Assigned Interventions |
---|---|
Experimental: Arm A: MEDI5752 MEDI5752 | Biological/Vaccine: MEDI5752 Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. |
Experimental: Arm B: MEDI5752 and chemotherapy MEDI5752, pemetrexed, carboplatin and paclitaxel. | Biological/Vaccine: MEDI5752 Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. Drug: Pemetrexed Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Drug: Carboplatin Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Drug: Paclitaxel or Nab-Paclitaxel Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
Active Comparator: Arm C: Pembrolizumab and chemotherapy pembrolizumab, pemetrexed, and carboplatin | Drug: Pemetrexed Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Drug: Carboplatin Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation Biological/Vaccine: Pembrolizumab Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.