Atamparib in Patients With Advanced Solid Tumors (PARP7)

Nerviano Medical Sciences (Shanghai) Ltd.

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Solid Tumor; NSCLC Adenocarcinoma

Treatments: Drug: atamparib RP2D; Drug: atamparib escalation levels

Study type: Interventional

Funder types: Industry

Identifiers

NCT07374419

PRP7A-ATA-001

Details and patient eligibility

About

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).

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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178 participants in 5 patient groups

monotherapy escalation

Experimental group

Description:

Atamparib

Treatment:

Drug: atamparib escalation levels

Espansion Arm a

Experimental group

Description:

Atamparib

Treatment:

Drug: atamparib RP2D

Expansion Arm b

Experimental group

Description:

Atamparib

Treatment:

Drug: atamparib RP2D

Expansion Arm c

Experimental group

Description:

Atamparib

Treatment:

Drug: atamparib RP2D

Expansion Arm d

Experimental group

Description:

Atamparib

Treatment:

Drug: atamparib RP2D