Trial Outcomes & Findings for Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours (NCT NCT04808362)

NCT ID: NCT04808362

Last Updated: 2024-04-25

Results Overview

Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months
• Results posted on: 2024-04-25

Participant Flow

22 patients at 3 sites

Participant milestones

Measure	OMO-103 OMO-103 will be administered intravenously as 30 min infusion once weekly
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours

Baseline characteristics by cohort

Measure	OMO-103 n=22 Participants OMO-103 will be administered intravenously as 30 min infusion once weekly
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Spain	22 participants n=5 Participants

PRIMARY outcome

Timeframe: DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months;

Population: safety population

Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;

Outcome measures

Measure	OMO-103 n=22 Participants OMO-103 will be administered intravenously as 30 min infusion once weekly OMO-103: OMO-103 will be administered intravenously as 30 min infusion once weekly
Phase 1: Safety and Tolerability DLT DLT	1 participants
Phase 1: Safety and Tolerability TEAEs	18 participants
Phase 1: Safety and Tolerability SAEs	9 participants
Phase 1: Safety and Tolerability IRRs	10 participants

SECONDARY outcome

Timeframe: 0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion

Population: Safety population

Phase 1: elimination half life (t1/2) was determined via several timepoints from 0 up to 94 hours after end of infusion

Outcome measures

Measure	OMO-103 n=22 Participants OMO-103 will be administered intravenously as 30 min infusion once weekly OMO-103: OMO-103 will be administered intravenously as 30 min infusion once weekly
Phase 1: Elimination Half Life (t1/2)	38 hours Standard Deviation 19

Adverse Events

OMO-103

Serious events: 9 serious events

Other events: 22 other events

Deaths: 3 deaths

Serious adverse events

Measure	OMO-103 n=22 participants at risk OMO-103 will be administered intravenously as 30 min infusion once weekly OMO-103: OMO-103 will be administered intravenously as 30 min infusion once weekly
Gastrointestinal disorders Bile Duct Obstruction	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Nervous system disorders Hydrocephalus	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Epigastralgia	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
General disorders IRR	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Blood and lymphatic system disorders Worsening anemia	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Inguinal Hernia	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Bowel Obstruction	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Injury, poisoning and procedural complications Back Pain	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Endocrine disorders Hypoglycemia	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Infections and infestations Bacteremia	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Respiratory, thoracic and mediastinal disorders Respiratory Insufficiency	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant disease progression	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
General disorders Back Pain	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Cardiac disorders Pericardial Effusion	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.

Other adverse events

Measure	OMO-103 n=22 participants at risk OMO-103 will be administered intravenously as 30 min infusion once weekly OMO-103: OMO-103 will be administered intravenously as 30 min infusion once weekly
Injury, poisoning and procedural complications Infusion Related Reactions IRR	45.5% 10/22 • Number of events 43 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Blood and lymphatic system disorders Anemia	31.8% 7/22 • Number of events 8 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Cardiac disorders Pericardial Effusion	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Cardiac disorders Supraventricular tachycardia	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Eye disorders Cataract	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Nausea	13.6% 3/22 • Number of events 4 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Abdominal pain	18.2% 4/22 • Number of events 4 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Diarrhea	13.6% 3/22 • Number of events 3 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Obstipation	4.5% 1/22 • Number of events 2 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Anal Hemorrhage	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Vomiting	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Pancreatitis	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Gastrointestinal disorders Gastroointestinal Disorder	13.6% 3/22 • Number of events 3 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
General disorders General Disorders	50.0% 11/22 • Number of events 16 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Hepatobiliary disorders Hepatobiliary Disorder	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Infections and infestations Infections	18.2% 4/22 • Number of events 7 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Investigations Investigations	27.3% 6/22 • Number of events 14 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Metabolism and nutrition disorders Metabolism	18.2% 4/22 • Number of events 6 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	45.5% 10/22 • Number of events 20 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	22.7% 5/22 • Number of events 5 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Nervous system disorders Nervous System	9.1% 2/22 • Number of events 2 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Reproductive system and breast disorders Scrotal Edema	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	18.2% 4/22 • Number of events 8 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Vascular disorders Vascular Disorder	9.1% 2/22 • Number of events 2 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.
Injury, poisoning and procedural complications Osteoradionecrosis	4.5% 1/22 • Number of events 1 • AE were collected for each patient from signing informed consent until last follow-up which was in average 3 months but varied a lot from 4 day up to 536 days. no deviation. CTCAE version 5 was used.

Additional Information

Dr Niewel

Peptomyc

Phone: +34932543450

Email: mniewel@peptomyc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place