A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas

NCT05279300
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Phase
Phase 1
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Recruitment status
Suspended
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Participants
480
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Lead sponsor
CStone Pharmaceuticals
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Start date
2022-03-28
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Number of sites
37
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Summary
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.
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Short title
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
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Official title
A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activities of CS5001, an Anti-ROR1 Antibody-Drug Conjugate, Used as A Single Agent and in Combination With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Suspended
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Phase
Phase 1
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Study type
Interventional
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Reason stopped
The sponsor is temporarily pausing the trial to evaluate existing clinical data for long-term benefit-risk and optimize doses and dosing schedule.
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Completion date
2027-12-31
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First posted
2022-03-15
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Registry last updated
2026-08-21
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Primary completion date
2027-06-30
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Start date
2022-03-28
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Participants
480
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Participant count basis
Estimated
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Planned participants
480
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Protocol amendments
2
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Number of sites
37
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Registry sponsor category
Industry
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Lead sponsor
CStone Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05279300
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ClinicalTrials.gov ID
NCT05279300
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)

    Timeframe: About 6 months

    Participants will receive CS5001 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT).

  2. Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)

    Timeframe: About 6 months

    The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range.

  3. Incident and severity of adverse events

    Timeframe: Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first

  4. Objective Response Rate (ORR) (for dose expansion)

    Timeframe: Up to 2 years

    The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors.

  1. Concentration of CS5001 total antibody

    Timeframe: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first

  2. Concentration of anti-CS5001 antibodies

    Timeframe: Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.
  • For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.
  • For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed/refractory (R/R) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1/PD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment.
  • For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.
  • Life expectancy > 3 months.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
  • Have adequate organ function.

  • Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell transplantation based on the Investigator's judgment.
  • Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
  • For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and/or during study participation.
  • Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.
  • Has other acute or chronic medical or psychiatric conditions.
  • Has a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy.
  • Has peripheral edema, pericardial effusion, or ascites indicated for medical intervention or limiting activity of daily life. Or with a known history of peripheral vasculopathies.
  • Patients with any active infections requiring systemic therapy within 2 weeks prior to the administration of the first dose of the study drug.
  • Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).
  • Significant cardiovascular disease within 6 months prior to the first dose of the study drug.
  • Significant screening electrocardiogram (ECG) abnormalities.
  • Has received major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the administration of the first dose of the study drug.
  • Administration of a live vaccine within 28 days prior to the administration of the first dose of the study drug.
  • Has active graft versus host disease.
  • With known active alcohol or drug abuse.
  • Women who are pregnant or breastfeeding.
Sources for eligibility
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  • North Shore Hematology Oncology AssociatesEast Setauket, United States
  • Columbia U. - Herbert Irving Comprehensive Cancer CenterNew York, United States
  • BUMC - Mary Crowley Cancer Research Centers (MCCRC)Dallas, United States
  • Scientia Clinical Research LimitedRandwick, Australia
  • Ashford Cancer Centre ResearchAdelaide, Australia
  • Central Adelaide Local Health Network IncorporatedAdelaide, Australia
  • Royal Adelaide Hospital (RAH)Adelaide, Australia
  • Epworth Freemasons Medical CentreEast Melbourne, Australia
  • Epworth Foundation trading as Epworth HealthCareMelbourne, Australia
  • Anhui Provincial Cancer HospitalHefei, China
  • Anhui Provincial Hospital,Hefei, China
  • Beijing Cancer HospitalBeijing, China
  • Yanda Lu Dao Pei HospitalBeijing, China
  • The Cancer Hospital Affiliated to Chongqing UniversityChongqing, China
  • Fujian Cancer HospitalFuzhou, China
  • Guangdong Province HospitalGuangzhou, China
  • Sun YatSen University Cancer CenterGuangzhou, China
  • Guangxi Medical University Affiliated Tumour HospitalNanning, China
  • The Fourth Hospital of Hebei Medical UniversityShijiazhuang, China
  • Henan Cancer HospitalZhengzhou, China
  • Henan Provincial People's HospitalZhengzhou, China
  • Hubei Cancer HospitalWuhan, China
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhan, China
  • Hunan Cancer HospitalChangsha, China
  • Jiangsu province hospitalNanjing, China

And 12 more, listed on the interactive page.

Sources for sites
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Related records

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