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RecruitingPhase 1

AOH1996 for the Treatment of Refractory Solid Tumors

First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests the side effects and best dose of AOH1996 for adults with solid tumors that have not responded to standard treatment or who refuse standard treatment. AOH1996 may slow tumor growth by blocking proteins that cells need to grow. One study group allows people with a certain type of lung cancer whose cancer is stable or better on an EGFR-blocking drug.

This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older.
  • Sign a consent form and allow the study team to use stored tissue samples, if available.
  • Be able to care for yourself and be out of bed or a chair for at least half the day. Be expected to live more than 3 months.
  • Have a solid tumor that did not respond to standard treatments, or have refused those treatments.
  • For the Part B non-small cell lung cancer group: have cancer that has stayed stable or improved for at least 2 months on an EGFR-blocking drug.
  • If you or your partner could become pregnant, use approved birth control or avoid sex that could cause pregnancy during the study and for 30 days after the last dose. Hormonal birth control alone is not enough.
  • Have blood tests showing enough infection-fighting cells and platelets, which help blood clot, and liver and kidney function within study limits. Tests must be done within 14 days before treatment starts.
  • If you could become pregnant, have a negative pregnancy test.

Who can't join

  • Use dietary or herbal supplements, warfarin (a blood thinner), other study drugs, or chemotherapy. An EGFR-blocking drug is allowed in the lung cancer expansion group.
  • Use certain drugs that strongly affect the liver proteins CYP2C9 or CYP3A, or drugs that cannot be used with strong CYP3A4 inducers. These proteins affect how the body handles medicines.
  • Have trouble taking pills, such as trouble swallowing, poor absorption of medicine, or ongoing nausea or vomiting.
  • Are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
  • Have a known allergy to any ingredient in the study drugs.
  • Have had another cancer, unless it was a treated basal or squamous cell skin cancer, cervical cancer limited to its starting area, treated stage I or II cancer now fully gone, or another cancer with no disease for 3 years.
  • Have a past or current health problem that the study doctor thinks makes the study too risky. You may be checked again after recovery.
  • The study doctor thinks you may not be able to follow all study steps, including because of travel or scheduling problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Informed Consent and Willingness to Participate * 1\. Documented informed consent by the participant * 2\. Willingness to permit study team to obtain and use archival tissue, if already existing Age Criteria, Performance Status and Life Expectancy * 3\. Age: ≥ 18 years * 4\. ECOG performance status ≤ 2 * 5\. Life expectancy of \> 3 months Nature of Illness and Treatment History \_\_6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR TKI + AOH1996) cohort: patients with stable disease or better on EGFR TKI for at least 2 months) Contraception \_\_7. Agreement by females and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study medication. See Appendix B for guidelines. \- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only). Laboratory Criteria (to be performed within 14 days prior to Day 1) * 8\. ANC ≥ 1,500/mm3 * 9\. Platelets ≥ 100,000/mm3 : * 10\. Total serum bilirubin ≤ 1.5 x ULN * 11\. AST =\< 1.5 x ULN or =\< 3 x ULN with liver metastases * 12\. ALT =\< 1.5 x ULN or =\< 3 x ULN with liver metastases * 13\. Creatinine clearance of ≥ 60 mL/min per 24 hour urine or the Cockcroft-Gault * 14\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Exclusion Criteria Concomitant Medications/Therapies \_\_1. Dietary/herbal supplements * 2\. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed. * 3\. Warfarin * 4\. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers * 5\. Strong inhibitors or inducers of CYP2C9 * 6\. Strong inhibitors or inducers of CYP3A Other Illnesses and Conditions * 7\. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting). * 8\. Women who are or are planning to become pregnant or breastfeed * 9\. Known allergy to any of the components within the study agents and/or their excipients. * 10\. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. * 11\. Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection). Noncompliance \_\_12. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics). \*\*Eligibility should be confirmed per institutional policies.

Study sites (3)

AZ

CA