Health TrialsbyHealthPanel

A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCStone Pharmaceuticals

About this trial

This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Age ≥ 18 years on the day of signing informed consent.

Pathologically or cytologically confirmed, unresectable advanced solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), gastric cancer (GC), ovarian cancer (OC), cervical cancer (CC), etc.

Disqualifiers

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 either symptomatic, untreated, or requires therapy.

Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product.

Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CS2009

    Drug

    CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).

  • CS2009

    Drug

    CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 14/21-day cycles (Q2W/Q3W).

  • Pemetrexed

    Drug

    IV infusion

  • Carboplatin

    Drug

    IV infusion

  • Paclitaxel

    Drug

    IV infusion

  • Etoposide

    Drug

    IV infusion

  • Nab-paclitaxel

    Drug

    IV infusion

  • Oxaliplatin

    Drug

    IV infusion

  • Capecitabine

    Drug

    oral tablets

  • Docetaxel

    Drug

    IV infusion

  • Leucovorin

    Drug

    IV infusion

  • 5-FU

    Drug

    IV infusion

  • Cisplatin

    Drug

    IV infusion

  • Gemcitabine

    Drug

    IV infusion

  • Irinotecan

    Drug

    IV infusion

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 14 interventions

Trial outcomes

Primary outcomes

1

[Dose Escalation] Maximum tolerated dose (MTD) of CS2009

Participants will receive CS2009 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 CS2009

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
Cycle 1 (Up to 21 Days)
3

[Dose Escalation] Number of participants with adverse events (AEs)

Time frame
Up to approximately 2 years
4

[Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1

Time frame
Up to approximately 2 years

Secondary outcomes

1

[Dose Escalation & Expansion] Area under the curve (AUC) of CS2009

Time frame
Up to approximately 2 years
2

[Dose Escalation & Expansion] Maximum concentration (Cmax) of CS2009

Time frame
Up to approximately 2 years
3

[Dose Escalation & Expansion] Elimination half-life (t1/2) of CS2009

Time frame
Up to approximately 2 years
4

[Dose Escalation & Expansion] Minimum concentration (Cmin) of CS2009

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

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

CStone Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now