A Study of DXC014 in Patients With Advanced Solid Tumors.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou DAC Biotechnology Co., Ltd.

About this trial

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC014 in patients with Advanced Solid Tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements.

Male or female.

For other solid tumor patients: Age ≥18 years and ≤75 years;For prostate cancer patients: Age ≥18 years.

Disqualifiers

Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose >10 mg/day prednisone or equivalent for more than 3 consecutive days, or other anti-inflammatory drugs with equivalent activity (short-term use for preventing contrast agent allergy is allowed for enrollment).

Received systemic anti-tumor therapy or investigational drug treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; received palliative radiotherapy within 14 days prior to the first dose; received treatment with Chinese patent medicines or herbal medicines explicitly indicated for anti-tumor purposes in the NMPA-approved drug label within 1 week prior to the first dose.

History of solid organ transplantation.

Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and/or leptomeningeal metastases or spinal cord compression, with the following exceptions: asymptomatic and stable brain metastases, or participants who have received treatment for brain metastases with no evidence of new or enlarging brain metastases on imaging for at least 4 weeks and no related symptoms, and who have discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • DXC014

    Drug

    Dose Escalation DXC014, Cohort Expansion DXC014

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.

Time frame
28 days
2

Number of participants with adverse events (AEs)

The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.

Time frame
After first infusion of study drug, Through study completion an average of 1 year

Secondary outcomes

1

Maximum observed serum or plasma concentration (Cmax)

One of the pharmacokinetics parameters for DXC014 investigator shall assess the relationship between the events and investigational product.

Time frame
Through study completion an average of 1 year
2

Maximum serum drug time(Tmax)

One of the pharmacokinetics parameters for DXC014

Time frame
Through study completion an average of 1 year

Other outcomes

Sponsors and contacts

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