Health TrialsbyHealthPanel

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

ConditionsAdvanced Solid TumorAdvanced Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCStone Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CS5001

    Drug

    The dose and dosing schedule is decided by the Safety Monitoring Committee.

  • Rituximab

    Biological/Vaccine

    IV infusion

  • Gemcitabine

    Drug

    IV infusion

  • Oxaliplatin

    Drug

    IV infusion

  • Lenalidomide

    Drug

    PO

  • Cyclophosphamide

    Drug

    IV infusion

  • Doxorubicin

    Drug

    IV infusion

  • Vincristine

    Drug

    IV infusion

  • Prednisone

    Drug

    PO

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: Dose escalationExperimental treatment 1 intervention
Group B: Dose expansionExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)

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).

Time frame
About 6 months
2

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

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.

Time frame
About 6 months
3

Incident and severity of adverse events

Time frame
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)

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.

Time frame
Up to 2 years

Secondary outcomes

1

Concentration of CS5001 total antibody

Time frame
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

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

Other outcomes

1

Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part)

Time frame
About up to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CStone Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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