Clinical Trials in the USA / NCT05907980
Recruiting
Phase 1
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
NCT05907980 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Solid Tumor
Investigational drug(s) / intervention(s)
ROSE12: ROSE12 as a IV infusion
Atezolizumab: Atezolizumab as a IV infusion
Pembrolizumab: Pembrolizumab as a IV infusion
Study summary
This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.
Eligibility
* Age \>= 18 years at time of signing informed consent form (ICF)
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
* Adequate hematologic and end-organ function
* Life expectancy \>= 12 weeks
* Patients with histologic documentation of locally advanced, or metastatic solid tumor
* \[Dose-escalation Parts and Biopsy Parts\]Refractory or resistant to standard therapies or standard therapies are not available
* \[Dose-escalation Parts and Expansion Part\] Patients with confirmed availability of fresh tumor or representative tumor specimens
* \[Biopsy Parts\] Patients with accessible lesion(s)
* \[Expansion Parts\] Patients with ICI (immune checkpoint inhibitor)-refractory 2L-3L NSCLC (non-small-cell lung cancer) and 3L+ CRC (colorectal cancer)
Exclusion Criteria:
* Clinically significant cardiovascular or liver disease
* Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
* Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
* All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
* Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Active or history of clinically significant autoimmune disease
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
\[Expansion Part\]
* Prior treatment with investigational product which has MoA of Treg depletion
* Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1
Primary outcome measure(s)
- The maximum tolerated dose (MTD) and the recommended dose (RD) of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A and C) — From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
Incidence and nature of dose-limiting toxicities (DLTs) - Safety (All Parts) and tolerability (Part A, B, C and D) of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (Adverse Events) — From screening until study completion, treatment discontinuation or post-treatment follow up, assessed up to the end of the study (approximate 43 months)
Incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 - The maximum serum concentration (Cmax) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts) — From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)
The maximum serum concentration (Cmax) of ROSE12 - The minimum serum concentration (Cmin) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts) — From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)
The minimum serum concentration (Cmin) of ROSE12 - The area under the concentration time-curve (AUC) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts) — From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)
The area under the concentration time-curve (AUC) of ROSE12 - Preliminary anti-tumor activity of ROSE12 when administered in combination with atezolizumab or pembrolizumab (Part E and F) — From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)
Objective response rate (ORR), defined as the proportion of patients with an objective response (complete response \[CR\] or partial response \[PR\]) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| NEXT Oncology | Fairfax | Virginia | Recruiting |
| Aichi Cancer Center | Nagoya | Aichi-ken | Recruiting |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | Recruiting |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Recruiting |
| Kansai Medical University Hospital | Hirakata-shi | Osaka | Recruiting |
| Osaka International Cancer Institute | Osaka | Osaka | Recruiting |
| Kindai University Hospital | Sakai-shi | Osaka | Recruiting |
| Shizuoka Cancer Center | Nagaizumi-chō | Shizuoka | Recruiting |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Recruiting |
| The Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo | Recruiting |
More Chugai Pharmaceutical trials in the USA
Other trials for the same condition
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Active, not recruiting
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05907980 on ClinicalTrials.gov ↗ ← All trials in the USA