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
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
Treatments tested in this trial
- CS2009
- CS2009
- Pemetrexed
- Carboplatin
- Paclitaxel
- Etoposide
- Nab-paclitaxel
- Oxaliplatin
- Capecitabine
- Docetaxel
- Leucovorin
- 5-FU
- Cisplatin
Treatment groups
660 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov