ART6043 for Metastatic Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Artios Pharma Ltd

Must be taking: PARPi

Disqualifiers: Pregnancy, MDS/AML, Brain metastases, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new cancer drug, ART6043, alone or with other drugs (Olaparib and Niraparib) in patients with advanced cancers that have genetic defects in DNA repair. The treatment aims to exploit the cancer cells' inability to fix their DNA, making it harder for them to survive. Olaparib is used to treat certain cancers by preventing the cancer cells from fixing their DNA, which makes it harder for them to survive.

Will I have to stop taking my current medications?

The trial requires that you stop taking all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives before starting the study. Endocrine and hormonal therapies for cancer must be stopped at least 7 days before the study, unless you are being treated for prostate cancer.

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors who've had prior taxane treatment, unless not medically advised. They should have an ECOG performance status of 0-2, adequate organ function, and a life expectancy of at least 12 weeks. It's also for those with specific genetic mutations in DDR genes and who consider PARPi therapy suitable. Pregnant individuals, those with certain gastrointestinal issues, brain metastases (unless treated), allergies to study drugs, MDS/AML or features suggestive of these conditions are excluded.

Inclusion Criteria

I have had less than or equal to one month of PARPi treatment.

I have finished any palliative radiotherapy before starting this study.

Radiologically evaluable and measurable and/or non-measurable disease

+13 more

Exclusion Criteria

Patients who are pregnant

My brain cancer has not worsened after treatment.

I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

+8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

≤4 weeks

Dose-escalation

Part A will evaluate ART6043 as monotherapy and in combination with PARPi in patients with advanced or metastatic cancer.

21-day cycles

Cycle 0 Days -2, -1, Cycle 1 Days 1, 8, 15, 16, Cycle 2 Days 1, 8, 15, Cycle 3 Day 1

Dose-expansion

Part B will confirm the safety of ART6043 in combination with PARPi and assess initial effectiveness compared to PARPi alone.

21-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after discontinuation

Participant Groups

The study tests ART6043 alone or combined with Olaparib or Talazoparib on patients with solid tumors. It aims to assess the safety and how well the body handles these treatments (pharmacokinetics) as well as their initial effectiveness against cancer.

5Treatment groups

Experimental Treatment

Group I: Part B2 (ART6043 in combination with a PARPi or a PARPi alone)Experimental Treatment3 Interventions

Patients with g/sBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be randomly assigned to receive ART6043 in combination with a PARPi or a PARPi alone (Olaparib or Niraparib).

Group II: Part B1 (ART6043 in combination with a PARPi)Experimental Treatment3 Interventions

Patients with g/sBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be assigned to receive ART6043 in combination with a PARPi (Olaparib or Niraparib).

Group III: Part A3 (ART6043 in combination with Niraparib)Experimental Treatment2 Interventions

Patients with advanced or metastatic cancer and with PARPi as an appropriate treatment option will be given ART6043 in combination with Niraparib once daily (QD) in 21-day cycles.

Group IV: Part A2 (ART6043 in combination with Olaparib)Experimental Treatment2 Interventions

Patients with advanced or metastatic cancer and with PARPi as an appropriate treatment option will receive ART6043 in combination with Olaparib twice daily (BID) in 21-day cycles.

Group V: Part A1 (ART6043 as monotherapy)Experimental Treatment1 Intervention

Patients with advanced or metastatic cancer will receive ART6043 administered in 21-day cycles.