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Advanced Malignant Solid TumorsPhase 1NCT06717750

A Study of CSCJC3456 in Patients With Advanced Malignant Tumors

A Phase 1 study testing CSCJC3456 tablet in people with Advanced Malignant Solid Tumors, run by Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) 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

This is a multicenter, open-label, phase I clinical study employing a dose-escalation and cohort-expansion design to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in patients with advanced malignant solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
CSCJC3456 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesChina
Study dates
13 Feb 2025to 30 Jun 2028
Phase
Phase 1
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

  • Voluntarily sign the informed consent form and follow protocol requirements;
  • Aged 18 to 75 (both inclusive), male or female, regardless of race;
  • Expected survival period ≥ 12 weeks;
  • ECOG PS score ≤1;
  • Phase Ia study:
  • ● Participants with advanced malignant solid tumors confirmed by pathology or cytology, who have experienced disease progression despite standard treatment, are intolerant to standard treatment, or lack effective standard treatment; and who possess at least one measurable lesion in accordance with RECIST v1.1 criteria;
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  • Phase Ib study:
  • Cohort A (hepatocellular carcinoma, including at least 2 participants with FGFR4 positivity), Cohort B (colorectal cancer, including at least 2 participants with FGFR1 or FGFR2 positivity), Cohort C (gastric cancer (including adenocarcinoma at the gastroesophageal junction), including at least 2 participants with FGFR1 or FGFR2 positivity), Cohort D (recurrent/metastatic endometrial cancer, including at least 2 participants with FGFR2 or FGFR3 positivity), or other sensitive tumor types identified in phase Ia trial, confirmed by histology or cytology, who have failed or are intolerant to standard treatment. Investigators may adjust participant selection based on their response to treatment in the trial and communication with the sponsor.
  • Each cohort of participants had at least one measurable lesion that met the criteria of RECIST v1.1.
  • Before the first dose, the participant has recovered from the toxic effects of the previous last treatment (CTCAE grade ≤ 1, except for special conditions such as "hair loss" and "pigmentation"), and in addition, the investigator judges that the corresponding AE did not pose a safety risk;
  • Systolic blood pressure ≤150 mmHg, diastolic blood pressure ≤90 mmHg, and no changes in antihypertensive medication and dosage within 7 days prior to the first administration.
  • Adequate Organ and bone marrow function.
  • Female participants of childbearing age must undergo a serum pregnancy test 7 days before starting the study medication, and the result must be negative. They must also be willing to adopt a medically approved highly effective contraceptive measure (e.g., an intrauterine device, contraceptive pills, or condoms) during the study period and for 3 months after the last administration of study medication. Male participants whose partners are female of childbearing age should agree to adopt an effective contraceptive method during the study period and for 3 months after the last administration of study medication. Breastfeeding women should agree to cease breastfeeding during the study period and for 3 months after the last administration of study medication.
  • Have the gene sequencing results of the current tumor, or are willing to provide tumor tissue specimens (paraffin-embedded tissue blocks, or serial sections).
  • Specimens are preferably derived from recently collected and usable tumor tissues. For relevant instructions, please refer to the Central Laboratory Manual.
  • In cases where there is insufficient tumor tissue (e.g., insufficient number of available slides, including situations where no tissue specimens are available) and the investigator believes that another tumor tissue biopsy is unsafe, intolerable, infeasible, or the patient refuses, the patient can be enrolled in the study after discussion with the sponsor.

Who cannot join

  • Previous or current diagnosis of other types of malignancy, except for the following:
  • Radically cured basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast cancer in situ;
  • Second primary cancer that has been cured with no recurrence within 5 years;
  • Patients who are allergic to any component of the study drug or have a history of severe allergies;
  • Having received any of the following treatments or medications before the first study treatment:
  • Major surgery or major trauma occurred within 4 weeks before the first study drug, but diagnostic tissue biopsies are allowed. Severe trauma refers to unhealed wounds, ulcers, or fractures;
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  • Received treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications within 2 weeks before the first study drug treatment;
  • Received anti-neoplastic therapies (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks or 5 half-lives of the investigational drug prior to the first dose, whichever is shorter;
  • Have received a potent CYP2C8 or CYP3A4 inducer within 2 weeks before the first dose; Or have received potent CYP2C8 or CYP3A4 inhibitors with less than 5 half-lives before the first dose;
  • Have received medications known to significantly prolong the QT interval (e.g., class Ia and class III antiarrhythmic drugs) within 1 week or 5 half-lives of the investigational drug prior to the first dose, whichever is shorter;
  • Previously received treatment with FGFR inhibitors (e.g., pemetrexed, erdafilone, infigranib, forodesine, ponatinib, dovitinib, nintedanib, AZD4547, NVP-BGJ398, LY2874455, BAY1163877, etc.);
  • Patients with a history of central nervous system metastasis or spinal cord compression. Those who meet the following criteria can be enrolled:
  • Patients who have clearly received treatment and have been clinically stable for 4 weeks after discontinuing anticonvulsants and steroids prior to the first administration of the study drug (definition of clinical stability: no clinical accompanying symptoms such as intracranial hypertension or neurological symptoms within 4 weeks, and imaging findings indicating stable lesions within 4 weeks prior to the first administration of the drug);
  • For patients with brain metastases, ≥21 days from whole brain radiation therapy (WBRT) to the first study treatment administration, ≥7 days from stereotactic radiosurgery (SRS) to the first study treatment administration, or ≥28 days from surgical resection to the first study treatment administration;
  • Advanced patients who have symptoms, spread to viscera, and are at risk of life-threatening complications in a short period of time, patients who have undergone at least two paracentesis and drainage within 4 weeks before the first dose, or patients who have undergone one paracentesis and drainage but have unstable pleural effusion, peritoneal effusion, or pericardial effusion;
  • Within the 6 months prior to screening, having a cardiovascular disease.
  • Uncontrolled systemic diseases, such as diabetes, hypertension, etc.;
  • Currently suffering from sudden pulmonary disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, etc., except for local interstitial pneumonia induced by radiotherapy;
  • Patients with a clear tendency towards gastrointestinal bleeding, including the following conditions: those with a history of black stool or hematemesis within 2 months; those whom investigators believe may have a high risk of major gastrointestinal bleeding;
  • Patients with previous or current grade ≥3 gastrointestinal perforation or visceral fistula;
  • Grade ≥3 diarrhea during the screening period;
  • Evidence of active infection.
  • Positive for human immunodeficiency virus (HIV RNA) or treponema pallidum antibodies;
  • Have multiple factors that affect oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or a condition that the investigator has judged to severely affect gastrointestinal absorption;
  • Having a clear history of neurological or psychiatric disorders, including epilepsy or dementia;
  • Having received any investigational drug within 4 weeks before the first administration, or participating in another clinical study at the same time (excluding the following situations: the patient is participating in an observational, non-interventional clinical study, or is in the follow-up period of an interventional clinical study; or the last study drug has been taken for more than 5 half-lives);
  • Patients deemed unsuitable for inclusion in this study by the investigators.

Trial locations and contacts

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

Ning Li, M.D. contact

8610-87788713

lining@cicams.ac.cn

China2 sites, 2 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Ning Li, 8610-87788713, lining@cicams.ac.cn

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Funan Liu, M.D.

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label, Single/Multiple-dose Escalation, and Cohort Expansion Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Oral CSCJC3456 Tablets in Patients With Advanced Malignant Solid Tumors

This is a multicenter, open-label, phase I clinical study employing a dose-escalation and cohort-expansion design to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in patients with advanced malignant solid tumors.

Read the detailed description

CSCJC3456 is a multi-target tyrosine kinase inhibitor, and this is its first-in-human trial. This open-label, non-randomized, single-arm study uses a dose-escalation and cohort-expansion design and consists of two parts: Phase Ia and Phase Ib.

Phase Ia is a single- and multiple-dose escalation trial with an open-label design, aiming to evaluate the safety, tolerability, PK, and PD of CSCJC3456 tablets, to assess preliminarily antitumor efficacy, and to recommend the dose and regimen for Phase Ib.

Phase Ib is a single-arm cohort-expansion study in patients with four selected types of solid tumors, using the recommended dose and dosing cycle from Phase Ia. The final tumor types to be included Phase Ib will be adjusted based on the safety and efficacy data from Phase Ia.

Being tested
CSCJC3456 tablet
Keywords
Neoplasms, Antineoplastic Agents, Tyrosine Kinase Inhibitors, Protein Kinase Inhibitors
Medical subject headings
Neoplasms

What participants receive

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

  • CSCJC3456 tabletDrug

    • Phase Ia: Single and Multiple Dose Escalation. Oral administration, 5-540 mg/day, once or twice daily (QD or BID). Treatment may be given continuously or intermittently as 3 weeks on/1 week off (28-day cycle) or 2 weeks on/1 week off (21-day cycle).
    • Phase Ib: Cohort Expansion. The dosage and dosing regimen will follow the recommended dose and dosing schedule derived from the Phase Ia study.
Study groups in NCT06717750
Study groupRoleWhat they receive
CSCJC3456 monotherapyExperimental* Phase Ia: Single and Multiple Dose Escalation. * Phase Ib: Cohort Expansion.
Receives: Drug: CSCJC3456 tablet

What is being measured

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

  1. Phase Ia: Dose Limiting Toxicity (DLT)

    Number and proportion of individuals experiencing DLT. According to the NCI-CTCAE V5.0 toxicity evaluation criteria, DLT is defined as a certain level of toxicity related to the study drug (including definitely related, probably related, and possibly related) occurring during the first treatment cycle (C0D1~C1D21) of single and multiple administrations.

    Measured: From first dosing at cycle 0 to the end of cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  2. Phase Ia: Maximum Tolerated Dose (MTD)

    MTD is defined as the maximum dose at which the number of cases with DLT is ≤1/6 during the DLT observation period. To determine MTD, 6 evaluable participants are required.

    Measured: From first dosing at cycle 0 to the end of cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  3. Phase Ia: Assessment of safety and toxicity profile

    Number of participants who experienced AEs, SAEs, and changes in physical examination, vital signs, ECOG score, imaging examination, laboratory tests, and 12-lead electrocardiogram, etc.

    Measured: From enrollment until the 28 days after the last study dose.

  4. Phase Ib: Objective Response Rate (ORR)

    ORR is defined as the proportion of participants whose tumors have achieved complete response (CR) and partial response (PR) after treatment, with response confirmed at least 4 weeks after the first assessment of CR or PR.

    Measured: From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

Secondary outcomes (12)

  1. Phase Ia and Phase Ib: Terminal Phase Half-life (t1/2 )

    Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.

    Measured: From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  2. Phase Ia and Phase Ib: Maximum plasma concentration (Cmax)

    Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.

    Measured: From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  3. Phase Ia and Phase Ib: Time to reach Cmax (tmax)

    Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.

    Measured: From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  4. Phase Ia and Phase Ib: Area Under the Curve (AUC)

    Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.

    Measured: From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  5. Phase Ia and Phase Ib: Apparent Volume of Distribution (Vz/F)

    Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.

    Measured: From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  6. Phase Ia and Phase Ib: Apparent Clearance Rate (CL/F)

    Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.

    Measured: From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

  7. Phase Ia: Objective response rate (ORR)

    ORR is defined as the proportion of participants whose tumors achieve complete response (CR) or partial response (PR) after treatment.

    Measured: From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

  8. Phase Ia and Phase Ib: Disease control rate (DCR)

    DCR is defined as the proportion of participants whose tumors achieve complete response (CR), partial response (PR), or stable disease (SD) after treatment.

    Measured: From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

  9. Phase Ia and Phase Ib: Durable objective response (DOR)

    DOR is defined as the period from the start of objective response recorded to the first occurrence of tumor progression or death due to any cause.

    Measured: From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

  10. Phase Ia and Phase Ib: Progression-free survival (PFS)

    PFS is defined as the time period from the initiation of treatment to the occurrence of tumor progression or death due to any cause.

    Measured: From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

  11. Phase Ib: Overall survival (OS)

    OS is defined as the time from the initiation of treatment to death due to any cause.

    Measured: From enrollment to the date of death due to any cause (up to approximately 2 years).

  12. Phase Ib: Assessment of safety and toxicity profile

    Number of participants who experienced AEs, SAEs, and changes in physical examination, vital signs, ECOG score, imaging examination, laboratory tests, and 12-lead electrocardiogram, etc.

    Measured: From enrollment until the 28 days after the last study dose.

Timeline

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

  1. First posted5 Dec 2024
  2. Study start13 Feb 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06717750
Sponsor's protocol ID
CSCJC CA101
Status last verified
Sep 2026
First submitted
26 Nov 2024
Last updated
21 Sep 2026
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 study testing CSCJC3456 tablet in people with Advanced Malignant Solid Tumors, run by Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) 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 16 inclusion and 27 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 21 Sep 2026. 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 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.

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 Ning Li, M.D. (8610-87788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Dose Limiting Toxicity (DLT) (time frame: From first dosing at cycle 0 to the end of cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.). The study lists 4 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 NCT06717750.

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 21 Sep 2026.

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