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Solid TumorPhase 1/2NCT06016062

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

A Phase 1/2 study testing RC148 Monotherapy, RC148+docetaxel Combination Therapy and RC148+RC48 Combination Therapy in people with Solid Tumor, run by RemeGen Co., Ltd. at 31 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
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
RC148 Monotherapy, RC148+docetaxel Combination Therapy and RC148+RC48 Combination Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
31 sitesChina
Study dates
14 Sep 2023to 31 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 years and older
  • 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 years (phase Ⅰ), 18 to 75 years old (Including 18 and 75 years, phase Ⅱ).
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Projected life expectancy of at least 12 weeks.
  • At least one measurable target lesion based on imaging according to RECIST v1.1 criteria (For patients who have received prior radiotherapy, radiotherapy-treated lesions may be considered as target lesions if the lesion is measurable according to RECIST v1.1 criteria and there is evidence of significant progression after radiotherapy.);
  • Requirements for inclusion of subjects at different stages:
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  • Phase I (RC148 monotherapy): Patients with locally advanced unresectable or metastatic malignant solid tumors whose disease has progressed with standard therapy, or who are unable to tolerate standard therapy, or in whom the subject refuses standard therapy;
  • Phase II (Combination Therapies):
  • Cohort 1 (non-small cell lung cancer): Patients with locally advanced unresectable or metastatic malignant solid tumors with disease progression on standard therapy, or intolerance of standard therapy, or refusal of standard therapy.
  • Cohort 2 (HER2-expressing cervical cancer): Subjects with advanced non-small cell lung cancer diagnosed by histological or cytological examination, locally advanced or metastatic, with AGA- confirmed by prior genetic testing, who have received a PD-1/PD-L1 inhibitor and platinum-based chemotherapy as a first or second-line advanced treatment, and who have not received docetaxel chemotherapy.
  • Cohort 3 (HER2 expressing gastric cancer): Histologically and/or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) with HER2 expression (IHC ≥1+). Subjects who have progressed or are intolerant to standard first-line therapy only (PD-1/PD-L1 inhibitor + platinum-containing chemotherapy ± trastuzumab, and not including paclitaxel). Disease progression during neoadjuvant therapy and within 6 months of the end of adjuvant therapy will also be considered a failure of first-line therapy.
  • Cohort 4 (MSLN-expressing lung adenocarcinoma): Histologically or cytologically confirmed lung adenocarcinoma without other pathologic components; driver gene negative, MSLN-expressing (IHC ≥1+) advanced lung adenocarcinoma subjects who have received PD-1/PD-L1 inhibitor and platinum-based chemotherapy (combination or sequential) and have not received paclitaxel-based chemotherapy.
  • Cohort 5 (platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer): pathologic type needs to be high-grade serous ovarian cancer; Subjects who have progressed on prior 1-4 lines of antitumor therapies; Definition of platinum-resistance: 1) Patients who have received 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR), and then progressed between >3 months and ≤6 months after the date of the last platinum; 2) Patients who have received 2 or 3 lines of platinum-based therapies must have received at least 4 cycles of platinum and have progressed on or within 6 months after the last dose of platinum.
  • Cohort 6 (platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer): Pathological type needs to be high-grade serous EOC; Subjects who have received 1-4 lines of prior antitumor therapies were included.
  • Cohort 7 (MSLN-expressing cervical cancer): Subjects with recurrent or metastatic cervical cancer expressing mesothelin (MSLN) (IHC ≥1+) that is histologically confirmed, ineligible for surgery or radiotherapy, and has progressed after at least 1L of platinum-based chemotherapy.
  • Participants agree to provide pre-treatment archived/biopsied tumor samples for biomarker-related testing such as retrospective programmed cell death protein 1 (PD-L1) expression levels. Biopsies will be considered at screening only if archived samples are not available. Fresh tumor biopsies will not be considered if significant risk procedures are required per the discretion of the Investigator.
  • Adequate bone marrow, liver, and renal function defined as:
  • No platelet or red blood cell transfusion within 14 days prior to performing routine blood tests, no correction with thrombopoietin (TPO), erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or interleukin-11 (IL-11), absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, and Hemoglobin ≥ 90g/L.
  • Serum total bilirubin ≤1.5 × upper limit of normal (ULN), ALT, AST ≤2.5 × ULN (≤5 × ULN in case of known liver metastases), albumin ≥30 g/L International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.
  • Serum creatinine ≤ 1.5 x ULN. Urinalysis results for urinary protein <++.
  • For subjects in Cohort 1 (Non-Small Cell Lung Cancer) and Cohort 4 (Lung Adenocarcinoma) of the Phase II Combined Protocol, pulse oximetry (O2 saturation) measured under unoxygenated conditions was required to be >92%.
  • Cardiac function: left ventricular ejection fraction ≥50%.
  • 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 contraceptive device.

Who cannot join

  • Pregnant or lactating.
  • Cohort 1 in Phase II, patients with histologically or cytologically confirmed non-small cell lung cancer, other than squamous lung cancer and lung adenocarcinoma, (including subjects with squamous or adenocarcinoma in combination with other pathologic types of non-small cell lung cancer;) prior treatment with docetaxel, or an antitumor agent that targets VEGF/VEGFR; and treatment with at least 2 cycles of an immune checkpoint inhibitor, with a best response of PD, or best response of CR/PR/SD with disease progression within 6 months of first dose.
  • Cohorts 4-7 in Phase II, patients with ocular corneal conditions at screening such as congenital corneal dystrophy, meibomian gland dysfunction (MGD), viral keratitis (dendritic, map-like, corneal stromal keratitis), uveitis, corneal endothelial decompensation, glaucoma, iridocorneal endothelial syndrome (ICE).
  • Subjects with active hepatitis B or C; human immunodeficiency virus (HIV)-positive subjects.
  • Those who have received a live vaccine within 28 days prior to the first RC148 administration or who plan to receive any live vaccine during the study period.
  • Participant with a history of other acquired/congenital immunodeficiency diseases or organ transplantation.
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  • Active autoimmune disease requiring systemic therapy, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, or rheumatoid arthritis, within the past 2 years; however, alternative therapies are not considered systemic therapies and are permitted for use and enrollment.
  • Subject has received an immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to initiation of treatment with the study drug or has experienced permanent discontinuation of immunotherapy due to toxicity of immune checkpoint inhibitor therapy prior to receiving administration of the study drug.
  • Subjects who have participated in a clinical trial of another drug and received the test drug within 4 weeks prior to the first dose of RC148.
  • Prior concomitant treatment with antitumor agents targeting VEGF/VEGFR and PD-1/PD-L1 (except for subjects with cervical cancer). For cohorts 2-3 in Part 2, subjects with prior antibody-drug conjugates treatment. For cohorts 4-7 in Part 2, subjects with prior antibody-drug conjugates and MSLN-targeting drugs.
  • Known hypersensitivity or delayed hypersensitivity to certain components of the study drug or to similar drugs.
  • Participant who are under the treatment of anticoagulant drugs. Participants using prophylactic doses of heparin are eligible in the study.
  • Subject received last systemic antitumor therapy, including surgery, chemotherapy, radiotherapy, and biologic therapy within 4 weeks prior to the first study drug administration; received small molecule tyrosine kinase inhibitor therapy or immunotherapy within 2 weeks prior to the first drug administration; or received herbal therapy for antitumor indications within 1 week prior to the first drug administration or received bone/other solitary metastases within 2 weeks prior to the first study drug administration Palliative radiotherapy.
  • Previous adverse reactions resulting from previous anti-tumour therapies, which have not returned to Grade 1 according to NCI-CTCAE v5.0 at screening.
  • Presence of grade ≥2 sensory or motor neuropathy.
  • Presence of third interstitial fluid with clinical symptoms or requiring intervention.
  • Active infection of clinical significance judged by the investigator.
  • Active gastrointestinal bleeding, history of hemoptysis, peptic ulcer, or a hemorrhagic event with NCI CTCAE (V5.0) ≥ grade 2 within 4 weeks prior to screening; or the presence of severe esophagogastric varices, nosebleeds; and in the case of subjects with gastric cancer, a tumor lesion with a tendency to bleed.
  • Presence of systemic diseases that, in the judgment of the investigator, are not under stable control, including diabetes mellitus, hypertension, cirrhosis of the liver, etc.
  • Those with previous and current clinical manifestations or high risk factors for interstitial lung disease (ILD), drug-associated pneumonia, radiation pneumonitis, severely impaired lung function, or suspected interstitial lung disease.
  • Clinically relevant pyelonephrosis that cannot be reduced by ureteral stenting or percutaneous drainage.
  • History of gastrointestinal perforation and/or fistula, gastrointestinal obstruction, inflammatory bowel disease, or bowel resection within the past 6 months.
  • Screening QTc interval >450 ms (males), QTc interval >470 ms (females); previous family or personal history of long/short QT interval syndrome; history of ventricular arrhythmia considered clinically significant by the investigator or currently receiving antiarrhythmic medications or implantation of an arrhythmia defibrillation device.
  • Experienced an arterial/venous thromboembolic event such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, cerebral infarction, or experienced a history of hypertensive crisis or hypertensive encephalopathy within 6 months prior to initiation of study treatment.
  • History of myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass graft or vascular disease, New York Heart Association (NYHA) grade ≥3 heart failure within 6 months prior to screening; history of fulminant, acute, chronic relapsing, or persistent myocarditis, pericarditis, or epicarditis from any cause within 1 year prior to screening.
  • Subjects on systemic therapy with corticosteroids (daily prednisone ≥10 mg/day or equivalent dose of drug) or other immunosuppressive medications within 2 weeks of first study administration.
  • Subjects with the presence of brain metastases who have been previously treated for brain metastases may be considered for enrollment (exclusion of brain metastases from gastric cancer): provided that the disease is stable, no disease progression has occurred as determined by imaging within 4 weeks prior to dosing, and all neurological symptoms have returned to baseline levels, and that the use of radiation, surgical, or steroid therapy has been discontinued for at least 28 days prior to the first dose of the drug; in the case of carcinomatous meningeal metastases, regardless of their clinical stabilization of symptoms, should be excluded.
  • Major surgery or intervention with incomplete recovery (except tumor biopsy or puncture) within 4 weeks prior to the first dose of study drug; or gross needle aspiration biopsy or other minor surgery, excluding placement of vascular infusion devices, within 7 days prior to initiation of study drug therapy.
  • Screening imaging showing tumor invasion of large blood vessels or imaging evidence of tumor invasion of vital organs or risk of developing a fistula; or imaging evidence of tumor encircling a large blood vessel or entry into the study causing a risk of hemorrhage.
  • Other malignancies were present within 5 years before the initiation of study administration, except for malignancies that would be expected to be cured with treatment.
  • Previous or current uncontrollable mental illness.
  • Subjects with poor compliance who were not expected to cooperate in completing trial procedures.
  • Any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the Investigator, gives reason to suspect that the subject has a disease or condition that makes the subject unsuitable for the use of the investigational drug, or that would interfere with the interpretation of the results of the study, or that would place the subject at high risk.

Trial locations and contacts

31 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

31 sites in 1 country

China31 sites, 31 recruiting

  • Anhui Provincial Hospital

    Anhui

    Recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing

    Recruiting

  • Beijing University Cancer Hospital

    Beijing

    Recruiting

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing

    Recruiting

  • Jilin Cancer Hospital

    Changchun

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Recruiting

  • Hunan Second People's Hospital

    Changsha

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Recruiting

  • Jinan Central Hospital

    Jinan

    Recruiting

  • Qilu Hospital of shangdong university

    Jinan

    Recruiting

  • Shandong Cancer Hospital

    Jinan

    Recruiting

  • Meizhou People's Hospital

    Meizhou

    Recruiting

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    Nanning

    Recruiting

  • Nanyang City Center Hospital

    Nanyang

    Recruiting

  • Nanyang Second General Hospital

    Nanyang

    Recruiting

  • Shanghai Pulmonology Hospital

    Shanghai

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Recruiting

  • Shanxi Provincial Tumor Hospital

    Taiyuan

    Recruiting

  • Tongji Hospital, Tongji Medical College of HUST, China

    Wuhan

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China

    Wuhan

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Recruiting

  • Yunnan Cancer Hospital

    Yunnan

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

About this study

Official title: A Multi-center Phase I/II Trial to Evaluate the Efficacy and Safety of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

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.

Conditions
Solid Tumor
Being tested
RC148 Monotherapy, RC148+docetaxel Combination Therapy, RC148+RC48 Combination Therapy, RC148+RC88 Combination Therapy, RC148/Bevacizumab+RC88 Combination Therapy

What participants receive

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

  • RC148 MonotherapyDrug

    Also called RC148 for injection

    RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle

  • RC148+docetaxel Combination TherapyDrug

    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 TherapyDrug

    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 TherapyDrug

    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 TherapyDrug

    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 groups in NCT06016062
Study groupRoleWhat they receive
Phase1-RC148 monotherapyExperimentalParticipants 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.
Receives: Drug: RC148 Monotherapy
Phase2-Arm1 (NSCLC): RC148+docetaxelExperimentalRC148+docetaxel Combination Therapy： Participants receive RC148 (10mg/kg or 20mg/kg Q3W) in combination with docetaxel (75mg/m^2 Q3W).
Receives: Drug: RC148+docetaxel Combination Therapy
Phase2-Arm 2 (Cervical): RC148+RC48ExperimentalRC148+RC48 Combination Therapy: Participants receive RC148 (20mg/kg Q2W) in combination with RC48 (2.0mg/kg Q2W).
Receives: Drug: RC148+RC48 Combination Therapy
Phase2-Arm 3 (Gastric cancer) : RC148+RC48ExperimentalRC148+RC48 Combination Therapy: Participants receive RC148 (20mg/kg Q2W) in combination with RC48 (2.0mg/kg Q2W).
Receives: Drug: RC148+RC48 Combination Therapy
Phase2-Arm 4 (Lung Adenocarcinoma): RC148+RC88ExperimentalRC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).
Receives: Drug: RC148+RC88 Combination Therapy
Phase2-Arm 5 (Platinum-resistant Ovarian cancer) : RC148/Bevacizumab+RC88ExperimentalRC148+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).
Receives: Drug: RC148/Bevacizumab+RC88 Combination Therapy
Phase2-Arm 6 (Platinum-sensitive Ovarian cancer): RC148+RC88ExperimentalRC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).
Receives: Drug: RC148+RC88 Combination Therapy
Phase2-Arm 7 (MSLN-expressing Cervical cancer): RC148+RC88ExperimentalRC148+RC88 Combination Therapy: Participants receive RC148 (20mg/kg Q3W) in combination with RC88 (2.0mg/kg Q3W).
Receives: Drug: RC148+RC88 Combination Therapy

What is being measured

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

  1. Phase I：Maximum tolerated dose (MTD)/Maximum administered dose (MAD)

    MTD/MAD based on number of Dose limiting toxicity (DLT)

    Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-28)

  2. Phase I：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 RC148 treatment

    Measured: 28 days after first treatment

  3. Phase I：The incidence and severity of adverse events (AE)

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

    Measured: From the day of ICF sign to 28/90 days after the day of the last treatment

  4. Phase I：Recommended Phase 2 dose (RP2D)

    The RP2D may be selected as 1 dose level lower than the MTD and will be determined in discussion with the safety monitoring committee based on all available data

    Measured: 28 days or 1cycle

  5. Phase II: ORR, DCR, DoR, PFS based on RECIST v1.1 investigator assessment;

    Measured: 15 months

Secondary outcomes (10)

  1. Phase I：Overall 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

  2. Phase I：DCR

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

    Measured: 15 months

  3. Phase I：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. Phase I：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

  5. Phase I：Pharmacodynamic characterization of RC148

    PD-1 receptor occupancy in circulating T cells

    Measured: 15 months

  6. Phase I：Pharmacodynamic characterization of RC148

    Plasma free VEGF, total VEGF levels

    Measured: 15 months

  7. Phase I/II：Pharmacokinetics (PK) parameter

    Measured: 15 months

  8. Phase I/II：ADA incidence rate

    Measured: 15 months

  9. Phase II：- Incidence and severity of adverse events/serious adverse events (graded based on NCI CTCAE V5.0);

    Measured: 15 months

  10. Phase II：- Vital signs, physical examination, ECOG physical status score, 12-lead electrocardiogram, laboratory tests;

    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 posted29 Aug 2023
  2. Study start14 Sep 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
221 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06016062
Sponsor's protocol ID
RC148-C001
Status last verified
Jan 2025
First submitted
18 Aug 2023
Last updated
23 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 RC148 Monotherapy, RC148+docetaxel Combination Therapy and RC148+RC48 Combination Therapy in people with Solid Tumor, run by RemeGen Co., Ltd. at 31 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 23 inclusion and 33 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 23 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 31 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?

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)). 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 NCT06016062.

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 23 Jan 2025.

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