ART4215 for Advanced Cancer

Recruiting at 7 trial locations

Overseen By Sarah Cannon Development Innovations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Artios Pharma Ltd

Must be taking: Parp inhibitors

Must not be taking: Live vaccines

Disqualifiers: Pregnancy, HIV/AIDS, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 18 weeks

390 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing ART4215, an experimental oral drug, in patients with advanced cancers. It works by blocking an enzyme that helps cancer cells repair their DNA, potentially stopping their growth. The study aims to find a safe dose and understand its side effects and effectiveness.

Will I have to stop taking my current medications?

The trial requires participants to stop all previous cancer treatments for at least 21 days or 5 half-lives, whichever is shorter, before starting the study. This means you may need to stop taking your current cancer medications, but the protocol does not specify about other non-cancer medications.

Research Team

Erika Hamilton, MD

Principal Investigator

Tennessee Oncology

Timothy Yap, MBBS, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors suitable for PARP inhibitor treatment. Eligible participants may have had prior chemotherapy but not more than three regimens, and no previous PARP inhibitors unless specified. They must have at least one measurable tumor lesion, adequate organ function, and agree to use effective contraception.

Inclusion Criteria

Signed informed consent

Additional inclusion criteria for participants in dose expansion (Part B2): Advanced or metastatic cancer that is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study with characteristics indicative of sensitivity to pol theta inhibition. No prior treatment with a PARP inhibitor and must not have a disease for which there is an approved PARP inhibitor. At least 1 measurable lesion assessable using standard techniques by RECIST v1.1 or PCWG-3 guidelines. Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis

I stopped all cancer treatments at least 21 days ago and have recovered from their immediate effects.

Exclusion Criteria

Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: opportunistic HIV/AIDs-related infection(s) within the past 12 months, hepatitis B virus, or hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated [including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)] that is not in remission. Have MDS/AML or features suggestive of MDS/AML. Ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic). Moderate or severe cardiovascular disease. Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment; stable brain metastases are eligible. Received a live vaccine within 30 days before the first dose of study treatment. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study. Significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment. Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Additional exclusion criteria for participants in dose escalation (Part A3): Hypersensitivity to any of the components of niraparib

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ART4215 as monotherapy or in combination with talazoparib or niraparib in 21-day cycles

18 weeks

Every 6 weeks (±7 days) for 18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Every 9 weeks (±7 days) up to approximately 24 months

Treatment Details

Interventions

• ART4215
• Niraparib
• Talazoparib

Trial Overview ART4215 is being tested alone and alongside talazoparib or niraparib in patients with various cancers including breast cancer. The study aims to determine the safe dosage levels, side effects profile, and effectiveness of these treatments in combating cancer progression.

Participant Groups

Group I: Part B3 Experimental Treatment 2 Interventions

In Part B3, approximately 120 participants with HER2 negative BRCA breast cancers will be randomized 1:1 to either ART4215 in combination with talazoparib or talazoparib alone.

Group II: Part B2 Experimental Treatment 1 Intervention

In Part B2 dose expansion, up to 20 participants with solid cancers with characteristics indicative of sensitivity to pol theta inhibition will receive ART4215.

Group III: Part B1 Experimental Treatment 1 Intervention

In Part B1 dose expansion, up to 30 participants with solid cancers that have been treated with a PARP inhibitor for an approved indication will receive ART4215.

Group IV: Part A3 Experimental Treatment 2 Interventions

Part A3 will evaluate ART4215 given in combination with niraparib in 21-day cycles. Up to 30 participants will participate in this dose escalation arm.

Group V: Part A2 Experimental Treatment 2 Interventions

Part A2 will evaluate ART4215 given in combination with talazoparib in 21 day cycles. Up to 50 participants will participate in this dose escalation arm.

Group VI: Part A1 Experimental Treatment 1 Intervention

Part A1 will evaluate ART4215 monotherapy administered in 21 day cycles. Up to 90 participants will participate in this dose escalation arm.

Who Is Running the Clinical Trial?

Artios Pharma Ltd

Lead Sponsor

Trials

6

Recruited

1,600+