Health TrialsbyHealthPanel

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Subjects aged 18 to 75 years (inclusive).

2. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.

3. At least one measurable lesion, as defined by RECIST 1.1 criteria.

4. ECOG performance status of 0 or 1.

Disqualifiers

1. Previous use of antibody-conjugated drugs with similar loading agents for treatment.

2. Previous anti-tumor treatment drugs were not adequately removed.

3. Active leptomeningeal disease or uncontrolled CNS metastasis.

4. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • sirolimus (albumin-bound)

    Drug

    intravenous infusion

  • DP303c

    Drug

    intravenous infusion

  • SYS6043

    Drug

    intravenous infusion

  • SYS6002

    Drug

    intravenous infusion

  • SYS6010

    Drug

    intravenous infusion

Treatment groups

444 Participants
are divided into 4 treatment groups
Group A: sirolimus (albumin-bound)+ DP303cExperimental treatment 2 interventions
Group B: sirolimus (albumin-bound)+ SYS6043Experimental treatment 2 interventions
Group C: sirolimus (albumin-bound)+ SYS6002Experimental treatment 2 interventions
Group D: sirolimus (albumin-bound)+ SYS6010Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)

Time frame
Up to approximately 36 weeks after the first participant is enrolled
2

dose - limiting toxicities (DLT)

Time frame
Up to approximately 36 weeks after the first participant is enrolled
3

The recommended phase 2 dose

Time frame
Up to approximately 36 weeks after the first participant is enrolled

Secondary outcomes

Other outcomes

Sponsors and contacts

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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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