atamparib escalation levels: Bid, Oral, escalating at different dose levels
atamparib RP2D: Bid, oral, RP2D
Study summary
This is a multi-part, open-label, non-randomized phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib, an investigational agent, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) adenocarcinoma. The study comprises dose escalation (phase Ib) and expansion (phase II).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
1. Subject must be ≥18 years of age.
2. Histologically confirmed diagnosis of unresectable advanced or metastatic NSCLC adenocarcinoma.
3. Documented KRAS mutation status at study entry.
4. Have received at least one line of standard therapy and experienced radiographic tumor progression to the last administered treatment and have failed institutional standards of care.
5. Have measurable tumor lesions
6. ECOG 0-1
7. Adequate organ functions
Exclusion criteria:
1. Non-adenocarcinoma histology of NSCLC. Patients whose tumors have a mixed histology are ineligible.
2. Wtih oncogenic driver mutation other than KRAS for which an approved therapy is available but not adequately treated.
3. Known active GI disease that would impact the absorption
4. Clinically significant cardiac disease
5. Requiring the administration of strong inhibitors or inducers of CYP3A4, P-gp or BCRP.
6. Symptomatic, or untreated CNS lesions.
Primary outcome measure(s)
RP2D and MTD — 28 days after the last dose First cycle DLTs and all other available study data
Type, incidence and severity of adverse event — until 28 days after the last dose Safety and tolerability profile assessed by the CTCAE v6.0
Trial sites (1)
Facility
City
Region
Status
Unit 3.53, 3rd Floor, No. 5, Lane 720 Cailun Road, Pilot Free Trade Zone, Shanghai, P.R.China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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