A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

Sponsor
RemeGen Co., Ltd.
Study ID
NCT06016062
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RC148 Monotherapy — DRUG
    RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
  • RC148+docetaxel Combination Therapy — DRUG
    RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle； Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.
  • RC148+RC48 Combination Therapy — DRUG
    RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle； RC48 will be administered as an IV infusion on Day 1 of each 2-week cycle.
  • RC148+RC88 Combination Therapy — DRUG
    RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle； RC88 will be administered as an IV infusion on Day 1 of each 3-week cycle.
  • RC148/Bevacizumab+RC88 Combination Therapy — DRUG
    RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle; RC88 will be administered as an IV infusion on Day 1 of each 3-week cycle; Bevacizumab will be administered as an IV infusion on Day 1 of each 3-week cycle

Study Details

The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.

Key Dates

First listed
Aug 29, 2023
Start date
Sep 14, 2023
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
221 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase1-RC148 monotherapy
    Participants will be allocated to one of the following dose groups:1.0, 3.0, 10.0, 20.0, and 30.0mg/kg, and receive a treatment of RC148 followed by 28 days of dose limited toxicity (DLT) observation period.
  • Experimental: Phase2-Arm1 (NSCLC): RC148+docetaxel
    RC148+docetaxel Combination Therapy： Participants receive RC148 (10mg/kg or 20mg/kg Q3W) in combination with docetaxel (75mg/m\^2 Q3W).
  • Experimental: Phase2-Arm 2 (Cervical): RC148+RC48
    RC148+RC48 Combination Therapy: Participants receive RC148 (20mg/kg Q2W) in combination with RC48 (2.0mg/kg Q2W).
  • Experimental: Phase2-Arm 3 (Gastric cancer) : RC148+RC48
    RC148+RC48 Combination Therapy: Participants receive RC148 (20mg/kg Q2W) in combination with RC48 (2.0mg/kg Q2W).
  • Experimental: Phase2-Arm 4 (Lung Adenocarcinoma): RC148+RC88
    RC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).
  • Experimental: Phase2-Arm 5 (Platinum-resistant Ovarian cancer) : RC148/Bevacizumab+RC88
    RC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W). Bevacizumab+RC88 Combination Therapy: Participants receive Bevacizumab (15mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).
  • Experimental: Phase2-Arm 6 (Platinum-sensitive Ovarian cancer): RC148+RC88
    RC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).
  • Experimental: Phase2-Arm 7 (MSLN-expressing Cervical cancer): RC148+RC88
    RC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).

Primary Outcome Measure

Phase I：Maximum tolerated dose (MTD)/Maximum administered dose (MAD) [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-28) ]

Central Contacts

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