OSE-127 - Healthy Subjects | Phase 1 | Tango Therapeutics, Inc. | BiopharmaWatch

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OSE-127

Phase 1

Healthy Subjects | Small molecule | Other |Tango Therapeutics, Inc.|Last Updated: Dec 12, 2019

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker

Total Trials1

Total Enrollment63

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03980080	Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects	PHASE1	COMPLETED	63	—	—	Dec 19, 2018	Nov 4, 2019	Dec 12, 2019	1	Belgium

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Study Endpoints

Primary Endpoints

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in vital signs Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Findings in Telemetry Reported as Adverse Event

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation

12 weeks (for Part 1); 19 weeks (for Part 2)

Secondary Endpoints

Part 1 (SAD) & Part 2 (MAD) : Maximum Plasma Concentration [Cmax]

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Average serum Concentration over the dosing interval [Cavg]

12 weeks (for Part 1); 19 weeks (for Part 2)

Part 1 (SAD) & Part 2 (MAD) : Trough serum Concentration observed at the end of the dosing interval [Ctrough]

12 weeks (for Part 1); 19 weeks (for Part 2)

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
OSE-127: Part 1 (SAD), Cohort A & Cohort B	EXPERIMENTAL	-
Placebo: Part 1 (SAD), Cohort A & Cohort B	PLACEBO_COMPARATOR	-
OSE-127: Part 2 (MAD)	EXPERIMENTAL	-
Placebo: Part 2 (MAD)	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
OSE-127	DRUG	mAb antagonist to CD127 receptor (or IL-7Rα) Group 1-7 6 escalating dose level groups IV SC
Placebo	DRUG	Vehicle study drug

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Eligibility Criteria

Age Range18 Years — 65 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: 1. Male or female, aged 18 to 65 years (extremes included). Maximum two subjects aged between 60 and 65 (extremes included) are allowed per dose group. 2. Healthy volunteers (medically stable), as determined on the basis of medical history, vital signs, clinical laboratory testi...

Countries:Belgium

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