TerminatedPhase 1

Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors

Stopped: Sponsor Decision

United States25 participantsStarted 2022-10-03

Plain-language summary

This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have a negative pregnancy test (serum) at Screening.
✓. Agree to use at least one highly effective form of contraception during study treatment and after the last dose of ORM-5029.
✓. Agree to use at least one highly effective form of contraception during study treatment and after the last dose of ORM-5029.
✓. Refrain from donating sperm during their participation in the study and after the last dose of ORM-5029.

Exclusion criteria

✕. HIV Seropositive participants who are healthy and at low risk for AIDS-related outcomes can be considered eligible. HIV positive participants must be evaluated and discussed with the Medical Monitor, and should have:
✕. Participants who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks prior to the first dose of ORM-5029 and have undetectable HBV viral load prior to enrolment. Note: Participants must remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
✕. Participants with a history of HCV infection are eligible if they have received curative treatment and HCV viral load is undetectable prior to enrolment. Participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to enrolment.

What they're measuring

Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only]

Timeframe: DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL

Incidence of Adverse Events (AEs)

Timeframe: Every cycle (each cycle is 21 or 28 days) until study discontinuation; Approximately 30 months

Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]

Timeframe: Approximately 30 months

Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]

Timeframe: Approximately 30 months

Trial details

NCT IDNCT05511844

SponsorOrum Therapeutics USA, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-02

View on ClinicalTrials.gov More HER2-positive Breast Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have a negative pregnancy test (serum) at Screening.
✓. Agree to use at least one highly effective form of contraception during study treatment and after the last dose of ORM-5029.
✓. Agree to use at least one highly effective form of contraception during study treatment and after the last dose of ORM-5029.
✓. Refrain from donating sperm during their participation in the study and after the last dose of ORM-5029.

Exclusion criteria

✕. HIV Seropositive participants who are healthy and at low risk for AIDS-related outcomes can be considered eligible. HIV positive participants must be evaluated and discussed with the Medical Monitor, and should have:
✕. Participants who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks prior to the first dose of ORM-5029 and have undetectable HBV viral load prior to enrolment. Note: Participants must remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
✕. Participants with a history of HCV infection are eligible if they have received curative treatment and HCV viral load is undetectable prior to enrolment. Participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to enrolment.

What they're measuring

Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only]

Timeframe: DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL

Incidence of Adverse Events (AEs)

Timeframe: Every cycle (each cycle is 21 or 28 days) until study discontinuation; Approximately 30 months

Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]

Timeframe: Approximately 30 months

Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]

Timeframe: Approximately 30 months