A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors

NCT05907980
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
209
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Lead sponsor
Chugai Pharmaceutical
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Start date
2023-05-24
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Number of sites
14
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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.
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Short title
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
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Official title
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-10-31
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First posted
2023-06-18
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Registry last updated
2026-07-28
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Primary completion date
2027-10-31
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Start date
2023-05-24
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Participants
209
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Participant count basis
Estimated
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Planned participants
209
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Protocol amendments
2
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Number of sites
14
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Registry sponsor category
Industry
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Lead sponsor
Chugai Pharmaceutical
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05907980
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ClinicalTrials.gov ID
NCT05907980
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. 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)

    Timeframe: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)

    Incidence and nature of dose-limiting toxicities (DLTs)

  2. 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)

    Timeframe: 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

  3. 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)

    Timeframe: 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

  4. 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)

    Timeframe: 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

  5. 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)

    Timeframe: 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

  6. Preliminary anti-tumor activity of ROSE12 when administered in combination with atezolizumab or pembrolizumab (Part E and F)

    Timeframe: 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

  1. Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A, B, C and D)

    Timeframe: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    ORR, defined as the proportion of patients with an objective response on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.

  2. Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

    Timeframe: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    Disease control rate (DCR), defined as the proportion of patients who had an objective response or stable disease (SD) which is confirmed no less than 6 weeks after the start of treatment as the minimum duration, as determined by the investigator with use of RECIST v1.1.

  3. Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

    Timeframe: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    Duration of objective response (DoR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

  4. Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

    Timeframe: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    Progression-free survival (PFS), defined as the time from administration of first study treatment to the first occurrence of disease progression or death from any cause, as determined by the investigator according to RECIST v1.1.

  5. The maximum serum concentration (Cmax) of atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E)

    Timeframe: 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 atezolizumab

  6. The minimum serum concentration (Cmin) of atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E)

    Timeframe: 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 atezolizumab

  7. The area under the concentration-time curve (AUC) of atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E)

    Timeframe: 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 atezolizumab

  8. The maximum serum concentration (Cmax) of pembrolizumab for PK profile when administered in combination with ROSE12 (Part F)

    Timeframe: 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 24 months)

    The maximum serum concentration (Cmax) of pembrolizumab

  9. The minimum serum concentration (Cmin) of pembrolizumab for PK profile when administered in combination with ROSE12 (Part F)

    Timeframe: 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 24 months)

    The minimum serum concentration (Cmin) of pembrolizumab

  10. The area under the concentration-time curve (AUC) of pembrolizumab for PK profile when administered in combination with ROSE12 (Part F)

    Timeframe: 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 24 months)

    The area under the concentration-time curve (AUC) of pembrolizumab

  11. The immunogenicity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

    Timeframe: 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)

    Prevalence and incidence of anti-drug antibodies (ADAs) to ROSE12 and potential correlation with PK parameters and safety

  12. The immunogenicity of atezolizumab when administered in combination with ROSE12 (Part C, D and E)

    Timeframe: 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)

    Prevalence and incidence of ADAs to atezolizumab and potential correlation with PK parameters and safety

  13. The immunogenicity of pembrolizumab when administered in combination with ROSE12 (Part F)

    Timeframe: 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)

    Prevalence and incidence of ADAs to pembrolizumab and potential correlation with PK parameters and safety

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No
  • 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)

  • 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
Sources for eligibility
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  • University of Pennsylvania Perelman Center for Advanced MedicinePhiladelphia, United StatesRecruiting
  • Rhode Island HospitalProvidence, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • NEXT OncologyFairfax, United StatesRecruiting
  • Aichi Cancer CenterNagoya, JapanRecruiting
  • National Cancer Center Hospital EastKashiwa-shi, JapanRecruiting
  • Kanagawa Cancer CenterYokohama, JapanRecruiting
  • Kansai Medical University HospitalHirakata-shi, JapanRecruiting
  • Osaka International Cancer InstituteOsaka, JapanRecruiting
  • Kindai University HospitalSakai-shi, JapanRecruiting
  • Shizuoka Cancer CenterNagaizumi-chō, JapanRecruiting
  • National Cancer Center HospitalChuo-ku, JapanRecruiting
  • The Cancer Institute Hospital of JFCRKoto-Ku, JapanRecruiting
Sources for sites
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Sources for references
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Related records

Drugs (2)

Lead sponsors (1)

Targets (2)