A Study of CS23546 in Subjects With Advanced Tumors

ConditionAdvanced Tumors

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorChipscreen Biosciences, Ltd.

About this trial

The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female and ≥18 years of age on day of signing informed consent.

Histologically or cytologically confirmed unresectable advanced recurrent/refractory solid tumor or lymphoma that is failure or or intolerant of all standard therapy or for which no standard therapy is available.

Individuals are required to provide tumor tissue samples for prospective detection of Programmed cell death 1 ligand 1 (PD-L1) expression and/or Microsatellite instability (MSI) / the DNA mismatch repair (MMR) status. Subjects who cannot be provided during the dose escalation phase will be evaluated by the researchers and sponsors before deciding whether to enroll.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Disqualifiers

Received anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days before the first medication.

History of ≥ Grade 3 immune related Adverse Events (irAEs) or termination of treatment due to irAEs during prior treatment with Programmed death 1 (PD-1) /PD-L1 antibody.

Active autoimmune diseases present during the screening period and systemic treatment was received within 2 years before the first medication. Individuals who only require hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids used for adrenal or pituitary insufficiency) can be enrolled.

Presence of central nervous system metastasis and/or meningeal metastasis.

Trial design

Design model

Sequential

Treatments tested in this trial

CS23546
Drug
Tablets administered orally.

Treatment groups

156 Participants

are divided into 2 treatment groups

Group A: Dose escalationExperimental treatment 1 intervention

Group B: Dose expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dose Limiting Toxicities (DLTs)

DLT: Number of patients experienced any dose limited toxicity. MTD: One level lower than the dose level at which dose escalation was terminated due to DLT reasons.

Time frame

Day 1 through Day 27

Maximum Tolerated Dose (MTD)

MTD: One level lower than the dose level at which dose escalation was terminated due to DLT reasons.

Time frame

Day 1 through Day 27

Time to Cmax (Tmax)

Time to reach the Cmax for CS23546.

Time frame