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Advanced Solid TumorPhase 1/2NCT05205850

A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

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

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa… 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-ADC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
2 sitesChina
Study dates
3 Mar 2022to 1 Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Volunteer to participate in this study and sign written informed consent
  • 18 years old ≤ age ≤ 75 years old, no gender limit
  • ECOG physical status score is 0 or 1 point
  • The expected survival time exceeds 12 weeks
  • Standard treatment is ineffective (disease progression or no remission after treatment), patients who cannot tolerate standard treatment, locally advanced unresectable or metastatic malignant solid tumors
  • The subject agrees to provide freshly collected tumor tissue specimens or collected and preserved tumor tissue specimens within 2 years during the screening period for CLDN 18.2 testing, and must meet the following criteria： A.Phase I dose escalation stage/dose confirmation stage: patients with gastric cancer, esophageal cancer, gastroesophageal junction cancer, pancreatic cancer, ovarian cancer, and cholangiocarcinoma with positive Claudin 18.2 expression (membrane staining is observed in any tumor cells); B.Phase IIa Dose Expansion phase: (positive membrane staining observed in any tumour cell) patients with gastric/gastro-oesophageal adenocarcinoma, pancreatic cancer; C. Phase IIa dose-optimisation phase: patients with gastric/gastro-oesophageal adenocarcinoma with Claudin 18.2-positive (positive membrane staining observed in any tumour cell)
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  • According to the RECIST v1.1 standard, based on imaging examination (CT/MRI), there is at least one measurable or evaluable target lesion
  • Sufficient bone marrow, liver, and kidney functions (subject to the normal value of the clinical trial center): absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, hemoglobin ≥ 90 g/ L, serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT, AST or ALP ≤ 3 times ULN without liver metastasis; ALT, AST or ALP ≤ 5 times ULN with liver metastasis, serum creatinine ≤ 1.5 Times ULN, International Normalized Ratio (INR) ≤ 1.5 times ULN, APTT ≤ 1.5 times ULN
  • Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine

Who cannot join

  • Women who are pregnant or breastfeeding, or women whose blood pregnancy test results are positive during the screening period (female subjects who are infertile do not need to undergo a pregnancy test, such as hysterectomy and/or bilateral ovaries in the past Women with resection or amenorrhea ≥12 months)
  • Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), and human immunodeficiency virus antibody (HIV-Ab) during the screening period
  • Subjects with a prior history of other acquired, congenital immunodeficiency diseases; subjects who are preparing for or have previously undergone organ or bone marrow transplantation;
  • Those who have previously received targeted therapy drugs for Claudin 18.2; or participated in clinical trials of other drugs within 4 weeks before the first administration and received trial drugs
  • Have vaccinated within 4 weeks before the first dose or plan to vaccinate any vaccine during the study period
  • Allergic to known research drug ingredients or excipients
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  • Combined use of vitamin K antagonist anticoagulant drugs; combined use of therapeutic doses of heparin (subjects using preventive doses of heparin can be included in the study)
  • Received anti-tumor therapy (surgery, chemotherapy, radiotherapy, biological therapy) within 4 weeks before the first administration, and received palliative radiotherapy for bone metastases within 2 weeks
  • The toxicity of previous anti-tumor treatments has not returned to the level 0 or 1 of NCI-CTCAE v5.0 (except for hair loss)
  • There are clinical symptoms of pleural fluid, ascites, and pericardial effusions require drainage (patients who do not require drainage or whose drainage is discontinued and who do not have a significant increase in effusion within 5 days may be included in the study)
  • According to the judgment of the investigator, an active infection with clinical significance
  • Combined with other diseases that seriously endanger the safety of the subject or affect the completion of the test, such as gastrointestinal bleeding (within 4 weeks before the first dose), peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung Fibrosis, kidney failure, and uncontrolled diabetes
  • QTc interval during the screening period>480 ms (based on the average of 3 screening electrocardiograms); previous family or personal history of long/short QT interval syndrome; ventricular arrhythmia deemed clinically significant by the investigator Medical history, or currently receiving antiarrhythmic drug treatment, or implantation of arrhythmia defibrillation device
  • Past myocardial infarction (within 6 months before the first administration), severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade 3~4 heart failure, no Controlled hypertension
  • People who have had alcohol dependence or drug abuse in the past
  • Those who have received systemic steroid therapy for a long period of time (Note: Short-term use (≤ 7 days) and withdrawal> 2 weeks can be selected)
  • Patients who have previously or currently suffered from uncontrolled primary or metastatic brain tumors, and the investigator believes that patients who have been stabilized or whose local treatment has ended may be considered for inclusion in the group
  • Past or current peripheral neuropathy ≥ Grade 2
  • Past or current mental illness that is difficult to control
  • Subjects who have poor compliance and are not expected to cooperate to complete the test procedure
  • Other subjects deemed unsuitable to participate in clinical research by the investigator
  • Serious arterial/venous thrombosis or cardiovascular accident within 6 months prior to dose administration, such pulmonary embolism, cerebral infarction, cerebral hemorrhage, except for asymptomatic lacunar infarction that does not require clinical intervention;

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jianming Fang, ph.D contact

+8610-58075763

jianmingfang@hotmail.com

China2 sites, 2 recruiting

  • The first affiliated hospital, zhejiang universtity school of medicine

    Hangzhou, Zhejiang, 310009

    Nong Xu, M.D

    Not yet recruiting

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

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

    Recruiting

Other trials in China

About this study

Official title: An Open, Multi-center Phase I/IIa Clinical Study of RC118 for Injection in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors with Positive Expression of Claudin 18.2

In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 at RP2D doses for patients with different tumor types。

Read the detailed description

this study is an open, single arm, multi-center Phase I /IIa clinical study. In the phase I, patients with locally advanced unresectable or metastatic malignant solid tumors (gastric cancer, esophageal cancer, gastroesophageal junction cancer, pancreatic cancer, ovarian cancer, cholangiocarcinoma, etc.) that are positive for Claudin 18.2(positive membrane staining observed in any tumor cells) will be included. in Phase I dose escalation phase, 7 dose groups will be preset：0.25 mg/kg、0.5 mg/kg、1.0 mg/kg、1.5 mg/kg、2.0 mg/kg、2.5 mg/kg、3.0mg/kg; In phase I dose confirmation phase, it is initially considered to set up 1~2 dose groups according to the dose-escalation phase MTD/MAD, with 3~6 subjects in each group. In the phase IIa cohort expansion phase, with reference to the results of the phase I study, subjects were grouped according to different tumor types, there are 30 subjects in each group, initially considering the inclusion of Claudin 18.2 positive(a clear cut-off value will be defined based on the results of Phase I) locally advanced unresectable or metastatic gastric cancer, esophageal cancer, gastroesophageal junction cancer, and pancreatic cancer patients.(The specific tumor types and groups will be further adjusted based on the results of the phase I study).

Being tested
RC118-ADC

What participants receive

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

  • RC118-ADCDrug

    Also called RC118 for injection

    RC118 for injection is a novel antibody-drug conjugate, with a Claudin 18.2-targeting antibody and a microtube inhibitor

Study groups in NCT05205850
Study groupRoleWhat they receive
RC118-ADCExperimentalParticipants will be allocated to one of the following dose groups: 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3.0mg/kg, and receive a treatment of RC118-ADC followed by 14 days of dose limited toxicity (DLT) observation period.
Receives: Drug: RC118-ADC

What is being measured

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

  1. Dose limiting toxicity (DLT)

    In the DLT evaluation window (observation period 1-28 days after the first administration), according to the NCI-CTCAE v5.0 grading standard, the investigator or the sponsor believes that toxic reaction which are reasonably related to RC118 treatment

    Measured: 28 days after first treatment.

  2. The incidence and severity of adverse events (AE)

    Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: From the day of ICF sign to 28 days after the day of the last treatment

  3. Objective response rate (ORR)

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

    Measured: 15 months

Secondary outcomes (6)

  1. Disease Control Rate (DCR)

    Disease Control Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) or stable disease(SD)

    Measured: 15 months

  2. Progression-free survival (PFS)

    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 15 months

  3. Duration of Remission (DOR)

    Duration of response is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading

    Measured: 15 months

  4. Pharmacokinetic index

    Tmax ，etc.

    Measured: 15 months

  5. Immunogenicity

    Anti-drug antibody (ADA) positive samples, etc.

    Measured: 15 months

  6. Overall survival（OS）

    OS was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted25 Jan 2022
  2. Study start3 Mar 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205850
Sponsor's protocol ID
RC118-C001
Status last verified
Dec 2024
First submitted
17 Nov 2021
Last updated
27 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-ADC in people with Advanced Solid Tumor, run by RemeGen Co., Ltd. at 2 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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 27 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 2 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Jianming Fang, ph.D (+8610-58075763, jianmingfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: 28 days after first treatment.). The study lists 3 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 NCT05205850.

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 27 Jan 2025.

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