Clinical Trials Logo

Clinical Trial Summary

This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing volumes. Condition or Disease: Patient with advanced tumor which is clinically accessible for intratumoral injection Intervention/Treatment: Drug - RiMO-301 Radiation - Radiotherapy Phase: Phase 1


Clinical Trial Description

Primary Objectives: • The primary objective is to determine the maximum tolerated dose (MTD) of RiMO-301 as determined by toxicity observed in patients treated with palliative radiation doses Secondary Objectives: - To determine clinical response after RiMO-301 and radiotherapy as assessed by clinical response rate using clinical evaluation, imaging and/or symptom relief - To characterize adverse events of RiMO-301 in patients with advanced cancers - To evaluate the pharmacokinetics (PK) of RiMO-301 with radiation The target population is patients with clinically accessible lesions for intratumoral injection. Up to 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intratumor injection of RiMO-301 to 30 days after the completion of radiation treatment: - Grade 4 or greater treatment related hematologic or dermatologic toxicity - Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (excluding nausea, vomiting or diarrhea without maximal medical intervention) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03444714
Study type Interventional
Source Coordination Pharmaceuticals, Inc.
Contact Ze-Qi Xu, Ph.D.
Phone 6304155601
Email zq@coordinationpharma.com
Status Recruiting
Phase Phase 1
Start date April 10, 2018
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06245122 - A Study of CS23546 in Subjects With Advanced Tumors Phase 1
Not yet recruiting NCT06314087 - iTAPVR Study - Phase II Randomized Study Phase 2
Recruiting NCT05390528 - A Study Evaluating the Safety, Tolerability, Pharmacokinetic and Efficacy of HLX301(TIGIT×PDL1 Bispecific) in Locally Advanced/Metastatic Solid Tumors or Lymphoma Phase 1/Phase 2
Completed NCT02419417 - Study of BMS-986158 in Subjects With Select Advanced Cancers Phase 1/Phase 2
Completed NCT04808453 - Phase I Study of CPI-300 in Patients With Advanced Tumors Phase 1
Recruiting NCT05799183 - A SHR-1210 BE Study on Healthy Subjects Phase 1
Recruiting NCT05429008 - A Phase I Clinical Study of HMPL-A83 in Patients With Advanced Malignant Neoplasm Phase 1
Terminated NCT04198818 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors Phase 1/Phase 2
Not yet recruiting NCT05213767 - Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors Phase 1
Not yet recruiting NCT04151810 - Phase I Clinical Trial of CDP1 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05068856 - A Study of HRS2543 in Patients With Advanced Tumors Phase 1
Completed NCT03781362 - Study of CPI-100 in Patients With Advanced Tumors Phase 1
Recruiting NCT03908814 - Phase I Clinical Trial of Human Anti-PD-L1 Antibody Injection (LDP) in Patients With Advanced Malignant Tumors Phase 1
Recruiting NCT05061628 - The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor Phase 1
Recruiting NCT05867771 - A Study of PM1022 in Patients With Advanced Tumors Phase 1/Phase 2