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Advanced Solid TumorPhase 1/2NCT06038396

A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors

A Phase 1/2 study testing RC118, Toripalimab and RC148 in people with Advanced Solid Tumor, run by RemeGen Co., Ltd. at 18 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
RC118, Toripalimab and RC148
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
18 sitesChina
Study dates
3 Aug 2023to 31 Aug 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be able to participate in the study voluntarily and willing to provide written informed consent.
  • male or female 18 ≤ age ≤ 75 years old.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • The expected survival ≥12 weeks.
  • Enrollment of subjects with locally advanced or metastatic gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction who have a histologically confirmed diagnosis and have failed standard therapy.
  • Subjects who received ≤2 prior systemic therapies.
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  • Subjects agree to provide tumor tissue specimens for Claudin 18.2 and PD-L1 expression levels during the screening period. Samples should have moderate to high expression of Claudin 18.2 by membrane staining.
  • According to the RECIST v1.1, there is at least one measurable target lesion.
  • Sufficient heart, bone marrow, liver and kidney functions.
  • Fertile male or female subjects must agree to take effective contraceptive measures during the study period and for 6 months after the end of the last dose, such as double-barrier contraceptive methods(eg. condoms), oral or injectable contraceptives, intrauterine.

Who cannot join

  • Pregnant women, breastfeeding women or women with a positive blood pregnancy test result during the screening period (non-fertile women do not need to undergo a pregnancy test, such as women with a previous hysterectomy and/or bilateral oophorectomy or amenorrhea ≥12 months).
  • Subjects with active hepatitis B (HBsAg positivity and HBV DNA titre higher than the normal upper limit), active hepatitis C (HCVAb positivity and HCV RNA titre higher than the normal upper limit), and positive human immunodeficiency virus antibody (HIV-Ab) results during the screening period.
  • Subjects with a history of other acquired or congenital immunodeficiency diseases, or who have undergone organ or bone marrow transplantation.
  • Subjects who have previously received monoclonal antibody, double antibody targeting drugs, ADC, CAR-T and other therapeutic drugs targeting Claudin 18.2 or other ADCs with MMAE payload; or have participated in clinical trials and received investigational drugs within 4 weeks before the first dose.
  • Have vaccinated within 4 weeks prior to the first dose or plan to receive any live vaccine during the study.
  • Subjects are atallergic to the ingredients or excipients of the experimental drug.
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  • Subjects who have received anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy, or targeted therapy) within 4 weeks or less than 5 half-lives of the experimental drug prior to the start of the first dose; or who have received anti-tumor therapy with traditional Chinese medicine or immunomodulators within 2 weeks prior to the start of the first dose.
  • The toxicity of previous anti-tumor therapy has not returned to the level 0 or 1 as defined by NCI-CTCAE v5.0 (except for alopecia, pigmentation and other long-term toxicity ≤2 that cannot be recovered which was defined by investigators).
  • The clinical symptoms of pleural effusion, abdominal effusion, or pericardial effusion that requires drainage.
  • Active infection within 2 weeks prior to the first dose that requires systemic anti-inflammatory therapy.
  • Complicating other diseases that seriously endanger the safety of the subjects or affect the completion of the study, such as peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure and uncontrolled diabetes (Fasting blood glucose > 8.5 mmol/L, HbA1C ≥7.5%).
  • The tumor lesion has a bleeding tendency or has received blood transfusion treatment within 4 weeks prior to the first dose.
  • During the screening period, QTc interval >450 ms(male), QTc interval >470ms(female); previous family or personal history of long/short QT interval syndrome; A history of ventricular arrhythmia deemed clinically significant by the investigator, or currently receiving antiarrhythmic medication, or implantation of arrhythmia defibrillation device.
  • Previous myocardial infarction (within 6 months prior to the first dose), severe or unstable angina, coronary or peripheral artery bypass grafting, heart failure grade 3~4 defined by New York Heart Association (NYHA) and uncontrolled hypertension.
  • Experienced an arterial/venous thromboembolic event within 6 months prior to the study.
  • Active autoimmune disease that requires systemic treatment within 2 years prior to the study. Patients with vitiligo, psoriasis, alopecia or Grave's disease that not requires systemic treatment, hypothyroidism that only requires thyroid hormone replacement therapy, and type 1 diabetes only requires insulin replacement therapy may be included in the study.
  • Subjects with brain metastases and/or carcinomatous meningitis who have previously received related treatment may be considered for inclusion if their disease has been stable for at least 3 months, no imaging evidence of disease progression has been observed within 4 weeks prior to the first dose, all neurological symptoms have returned to baseline, and radiation, surgery, or steroid therapy has been discontinued at least 28 days prior to the first dose; cancerous meningitis should be excluded regardless of whether it is clinically stable.
  • Other malignant tumor within 5 years prior to the signature of informed consent.
  • Major surgery or interventional therapy was performed within 4 weeks prior to the first dose and did not fully recovered (except tumor biopsy and puncture).
  • For Phase II subjects:
  • Received an immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to the first treatment with the test drug;
  • Prior concurrent receipt of antitumor agents targeting VEGF/VEGFR and PD-1/PD-L1;
  • Experienced permanent discontinuation of immunotherapy due to toxicity of immune checkpoint inhibitor therapy prior to receiving administration of study drug;
  • Currently receiving anticoagulant medications (except for subjects on prophylactic doses of heparin).
  • A history of uncontrollable mental illness or subjects currently experiencing such conditions.
  • Subjects with poor compliance who are expected to be unable to complete the study.

Trial locations and contacts

18 sites in 1 country.

Xiaohong Su contact

+8610-65018841

na.su@remegen.com

Tianshu Liu, ph.D contact

+86-21-31587871

liu.tianshu@zs-hospital.sh.cn

18 sites in 1 country

China18 sites, 18 recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Shandong

    Recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong

    Recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong

    Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan

    Recruiting

  • The Second People's Hospital of Neijiang

    Neijiang, Sichuan

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai

    Tianshu Liu, ph.D, +86-21-31587871, liu.tianshu@zs-hospital.sh.cn

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Recruiting

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Recruiting

  • Xinyang Central Hospital

    Xinyang, Henan

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC118 in Combination with Toripalimab / RC148 for Patients with Claudin 18.2-Positive, Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to establish the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); The Phase II study will evaluate the efficacy and safety of RC118 in combination with Toripalimab or RC148 in patients with locally advanced or metastatic Gastric cancer/Gastro-esophageal junction cancer.

Being tested
RC118, Toripalimab, RC148

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC118Drug

    Also called RC118 for injection

    Dose A or dose B, Q2W

  • ToripalimabDrug

    Also called Toripalimab injection, JS001

    Fixed dose, Q3W

  • RC148Drug

    Fixed dose, Q3W Other Names: RC148 injection

Study groups in NCT06038396
Study groupRoleWhat they receive
Part A-RC118 plus ToripalimabExperimentalParticipants receive RC118- ADC(dose A or dose B) Q2W and Toripalimab (fixed dose) Q3W
Receives: Drug: RC118; Drug: Toripalimab
Part B-RC118 plus Toripalimab / RC148ExperimentalReferring to the results of the Part A, an extension cohort using RC118 plus Toripalimab /RC148 will be established.
Receives: Drug: RC118; Drug: Toripalimab; Drug: RC148

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase1: Dose limiting toxicity (DLT)

    Toxicity occurs within the DLT evaluation window (1-21 days after the first dose) that the investigator or sponsor believes to be reasonably associated with RC118 or Toripalimab according to NCI-CTCAE v5.0.

    Measured: The first 3 weeks (21 days) after the start of dosing at each dose level

  2. Phase1/2: Adverse events (AEs)

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

    Measured: [Time Frame: 15 months]

  3. Phase1: Maximum tolerated dose(MTD)

    Maximum tolerated dose(MTD)

    Measured: up to 12 months

  4. Phase1: Recommended Phase 2 Dose (RP2D)

    Recommended Phase 2 Dose (RP2D)

    Measured: up to 12 months

  5. Phase 2: Objective response rate (ORR)

    The proportion of patients whose BOR is a confirmed CR or PR. Tumor response will be evaluated using RECIST v.1.1.

    Measured: 15 months

Secondary outcomes (7)

  1. Disease Control Rate (DCR)

    The percentage of patients who have achieved an objective response of confirmed CR ,PR or SD as assessed by the investigator per RECIST v1.1)

    Measured: 15 months

  2. Progression-free survival (PFS)

    The time from first dose to disease progression(as assessed by investigators according to RECIST v1.1 criteria) (as measured by the first event).

    Measured: 15 months

  3. Duration of Remission (DOR)

    The time from first documentation of response (CR or PR) until the time of first documentation of disease progression or death.

    Measured: 15 months

  4. Overall survival (OS)

    The time from the date of the first dose of study treatment to the date of death.

    Measured: 15 months

  5. Phase 1: Objective response rate (ORR)

    The proportion of patients whose BOR is a confirmed CR or PR. Tumor response will be evaluated using RECIST v.1.1.

    Measured: 15 months

  6. Peak and valley concentrations of RC118, total antibody, and free MMAE

    Peak and valley concentrations of C118 binding antibody, total antibody, and free MMAE were observed.

    Measured: 15 months

  7. RC118 immunogenicity: The incidence, time of onset, duration of patients with anti-drug-antibody (ADA)

    RC118 immunogenicity: The incidence, time of onset, duration of patients with anti-drug-antibody (ADA)

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start3 Aug 2023
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038396
Sponsor's protocol ID
RC118-C002
Status last verified
Sep 2024
First submitted
1 Sep 2023
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RC118, Toripalimab and RC148 in people with Advanced Solid Tumor, run by RemeGen Co., Ltd. at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohong Su (+8610-65018841, na.su@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase1: Dose limiting toxicity (DLT) (time frame: The first 3 weeks (21 days) after the start of dosing at each dose level). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06038396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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