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

• ClinicalTrials.gov Identifier: NCT04808362
• Recruitment Status: Terminated
• First Posted: March 22, 2021
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024
• Sponsor: Peptomyc S.L.
• Information provided by (Responsible Party): Peptomyc S.L.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Advanced Solid Tumors; Pancreatic Cancer; CRC
• Intervention: Biological: OMO-103
• Enrollment: 22

Participant Flow

Recruitment Details	22 patients at 3 sites
Pre-assignment Details

Arm/Group Title	OMO-103
Arm/Group Description	OMO-103 will be administered intravenously as 30 min infusion once weekly
Period Title: Overall Study
Started	22
Completed	22
Not Completed	0

Baseline Characteristics

Arm/Group Title		OMO-103
Arm/Group Description		OMO-103 will be administered intravenously as 30 min infusion once weekly
Overall Number of Baseline Participants		22
Baseline Analysis Population Description		[Not Specified]
Age, Continuous [1]; Median (Full Range); Unit of measure: Years
	Number Analyzed	22 participants
		61; (32 to 73)
		[1] Measure Description: patients older than 18 years
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants
	Female	11 50.0%
	Male	11 50.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants
	Hispanic or Latino	0 0.0%
	Not Hispanic or Latino	22 100.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	22 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Spain	Number Analyzed	22 participants
		22

Outcome Measures

1. Primary Outcome

Title	Phase 1: Safety and Tolerability
Description	Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;
Time Frame	DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months;

Outcome Measure Data

Analysis Population Description

safety population

Arm/Group Title	OMO-103
Arm/Group Description:	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
Overall Number of Participants Analyzed	22
Measure Type: Number; Unit of Measure: participants
DLT DLT	1
TEAEs	18
SAEs	9
IRRs	10

2. Secondary Outcome

Title	Phase 1: Elimination Half Life (t1/2)
Description	Phase 1: elimination half life (t1/2) was determined via several timepoints from 0 up to 94 hours after end of infusion
Time Frame	0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	OMO-103
Arm/Group Description:	OMO-103 will be administered intravenously as 30 min infusion once weekly until progression
Overall Number of Participants Analyzed	22
Mean (Standard Deviation); Unit of Measure: hours
	38 (19)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	no deviation. CTCAE version 5 was used.
Arm/Group Title	OMO-103
Arm/Group Description	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
All-Cause Mortality
	OMO-103
	Affected / at Risk (%)
Total	3/22 (13.64%)
Serious Adverse Events
	OMO-103
	Affected / at Risk (%)	# Events
Total	9/22 (40.91%)
Blood and lymphatic system disorders
Worsening anemia † 1 [1]	1/22 (4.55%)	1
Cardiac disorders
Pericardial Effusion † 1 [2]	1/22 (4.55%)	1
Endocrine disorders
Hypoglycemia † 1 [1]	1/22 (4.55%)	1
Gastrointestinal disorders
Bile Duct Obstruction † 1 [1]	1/22 (4.55%)	1
Abdominal pain † 1 [3]	1/22 (4.55%)	1
Epigastralgia † 1 [2]	1/22 (4.55%)	1
Inguinal Hernia † 1 [1]	1/22 (4.55%)	1
Bowel Obstruction † 1 [1]	1/22 (4.55%)	1
General disorders
IRR † 1 [4]	1/22 (4.55%)	1
Back Pain † 1 [1]	1/22 (4.55%)	1
Infections and infestations
Bacteremia † 1 [2]	1/22 (4.55%)	1
Injury, poisoning and procedural complications
Back Pain † 1 [5]	1/22 (4.55%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant disease progression † 1 [6]	1/22 (4.55%)	1
Nervous system disorders
Hydrocephalus † 1 [1]	1/22 (4.55%)	1
Respiratory, thoracic and mediastinal disorders
Pleuritic pain † 1 [1]	1/22 (4.55%)	1
Pleural Effusion † 1 [2]	1/22 (4.55%)	1
Pulmonary Embolism † 1 [1]	1/22 (4.55%)	1
Respiratory Insufficiency † 1 [1]	1/22 (4.55%)	1
1 Term from vocabulary, MedDRA; † Indicates events were collected by systematic assessment; [1] not related, grade 3; [2] not related, grade 2; [3] not related , grade 2; [4] related, grade 3; [5] not related , grade 3; [6] not related, grade 5
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	OMO-103
	Affected / at Risk (%)	# Events
Total	22/22 (100.00%)
Blood and lymphatic system disorders
Anemia † 1	7/22 (31.82%)	8
Cardiac disorders
Pericardial Effusion † 1	1/22 (4.55%)	1
Supraventricular tachycardia † 1	1/22 (4.55%)	1
Eye disorders
Cataract † 1	1/22 (4.55%)	1
Gastrointestinal disorders
Nausea † 1	3/22 (13.64%)	4
Abdominal pain † 1	4/22 (18.18%)	4
Diarrhea † 1	3/22 (13.64%)	3
Obstipation † 1	1/22 (4.55%)	2
Anal Hemorrhage † 1	1/22 (4.55%)	1
Vomiting † 1	1/22 (4.55%)	1
Pancreatitis † 1	1/22 (4.55%)	1
Gastroointestinal Disorder † 1	3/22 (13.64%)	3
General disorders
General Disorders † 1	11/22 (50.00%)	16
Hepatobiliary disorders
Hepatobiliary Disorder † 1	1/22 (4.55%)	1
Infections and infestations
Infections † 1	4/22 (18.18%)	7
Injury, poisoning and procedural complications
Infusion Related Reactions IRR † 1	10/22 (45.45%)	43
Osteoradionecrosis † 1	1/22 (4.55%)	1
Investigations
Investigations † 1	6/22 (27.27%)	14
Metabolism and nutrition disorders
Metabolism † 1	4/22 (18.18%)	6
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder † 1	10/22 (45.45%)	20
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm † 1	5/22 (22.73%)	5
Nervous system disorders
Nervous System † 1	2/22 (9.09%)	2
Reproductive system and breast disorders
Scrotal Edema † 1	1/22 (4.55%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder † 1	4/22 (18.18%)	8
Vascular disorders
Vascular Disorder † 1	2/22 (9.09%)	2
1 Term from vocabulary, MedDRA; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr Niewel
• Organization: Peptomyc
• Phone: +34932543450 ext 8684
• EMail: mniewel@peptomyc.com

• Responsible Party: Peptomyc S.L.
• ClinicalTrials.gov Identifier: NCT04808362
• Other Study ID Numbers: OMO-103-01
• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Results First Submitted: October 16, 2023
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024