A Phase I Study of CS5007 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCStone Pharmaceuticals
About this trial
This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Evidence of a personally signed and dated informed consent document.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Being ≥ 18 years of age on the day of signing informed consent.
Pathologically or cytologically confirmed, unresectable advanced solid tumors.
Disqualifiers
Has disease that is suitable for local treatment administered with curative intent.
Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.
Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.
Trial design
Design model
Sequential
Treatments tested in this trial
CS5007
DrugCS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
[Dose Escalation] Maximum tolerated dose (MTD) of CS5007
Participants will receive CS5007 via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). The MTD will be determined, if any, by the number of participants who experience a dose limiting toxicity (DLT).
Time frame
Cycle 1 (Up to 21 Days)2
[Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS5007
The selection of tentative RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The tentative RP2D may be the MTD or a lower dose within the tolerable dose range.
Time frame
Up to approximately 2 years3
[Dose Escalation] The incidence and severity of adverse events (AEs)
Time frame
Up to approximately 2 years4
[Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1
Time frame
Up to approximately 2 yearsSecondary outcomes
1
[Dose Escalation & Expansion] Area under the curve (AUC) of CS5007
Time frame
Up to approximately 2 years2
[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS5007
Time frame
Up to approximately 2 years3
[Dose Escalation & Expansion] Time to maximum concentration (Tmax) of CS5007
Time frame
Up to approximately 2 years4
[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS5007
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov