## Protocol Section
### Identification Module
**NCT ID:** NCT06419634

**Brief Title:** Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

**Official Title:** Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

#### Organization Study ID Info
**ID:** CA235-0001
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2030-09-16

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

### Conditions Module

**Conditions:**

- Acute Myeloid Leukemia

- Myelodysplastic Syndrome

**Keywords:**

- BMS-986497

- First-in-Human

- ORM-6151

- Acute myeloid leukemia (AML)

- Myelodysplastic syndrome (MDS)

- Cluster of differentiation 33 (CD33)

- G1 to S phase transition 1 (GSPT1)

- Open label study

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BMS-986497

**Label:** Part 1: Dose Escalation BMS-986497

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: BMS-986497

**Label:** Part 2: Dose Expansion BMS-986497

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part 1: Dose Escalation BMS-986497

- Part 2: Dose Expansion BMS-986497

**Description:** Specified dose on specified days

**Name:** BMS-986497

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of dose-limiting toxicities (DLTs)

**Time Frame:** Up to 21 days

**Measure:** Incidence of treatment-emergent adverse events (TEAEs)

**Time Frame:** Up to 2 years

**Measure:** Determine the Recommended Phase 2 Dose (RP2D)

**Time Frame:** Up to 2 years

#### Secondary Outcomes

**Measure:** Maximum concentration (Cmax)

**Time Frame:** Up to 2 years

**Measure:** Time to reach Cmax (Tmax)

**Time Frame:** Up to 2 years

**Measure:** Area under the curve from time 0 to last quantifiable concentration (AUC0-last)

**Time Frame:** Up to 2 years

**Measure:** Overall response rate (ORR)

**Time Frame:** Up to 4 years

**Measure:** Duration of response (DoR)

**Time Frame:** Up to 4 years

**Measure:** Best overall response (BOR)

**Time Frame:** Up to 4 years

**Measure:** Complete remission (CR)

**Time Frame:** Up to 4 years

**Measure:** Complete remission with incomplete hematologic recovery (Cri)

**Time Frame:** Up to 4 years

**Measure:** Complete remission with partial hematologic recovery (CRh) rate

**Time Frame:** Up to 4 years

**Measure:** Event-free survival (EFS)

**Time Frame:** Up to 4 years

**Measure:** Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)

**Time Frame:** Up to 4 years

**Measure:** Incidence of Anti-drug antibody (ADA) against BMS-986497

**Time Frame:** Up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
* Detectable levels of cluster of differentiation 33 (CD33) expression.
* Failed alternative therapies with established benefit.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.

Exclusion Criteria:

* Acute Promyelocytic Leukemia.
* Clinically active central nervous system leukemia.
* Active malignant solid tumor.
* Pregnant or breastfeeding.
* Other protocol-defined inclusion/exclusion criteria apply.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain NCT # and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Haven

**Contacts:**

***Contact 1:***

- **Name:** Site 0011

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0011

**State:** Connecticut

**Zip:** 06510

**Location 2:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Name:** Site 0010

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0010

**State:** Illinois

**Zip:** 60611

**Location 3:**

**City:** Boston

**Country:** United States

**Facility:** Local Institution - 0007

**State:** Massachusetts

**Zip:** 02114

**Location 4:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Name:** Site 0014

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0014

**State:** Massachusetts

**Zip:** 02114

**Location 5:**

**City:** Saint Louis

**Country:** United States

**Facility:** Local Institution - 0013

**State:** Missouri

**Zip:** 63110

**Location 6:**

**City:** Hackensack

**Contacts:**

***Contact 1:***

- **Name:** Site 0008

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0008

**State:** New Jersey

**Zip:** 07601

**Location 7:**

**City:** New York

**Country:** United States

**Facility:** Columbia University Irving Medical Center

**State:** New York

**Zip:** 10032

**Location 8:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Name:** Site 0006

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0006

**State:** Texas

**Zip:** 77030

**Location 9:**

**City:** Fairfax

**Country:** United States

**Facility:** Local Institution - 0009

**State:** Virginia

**Zip:** 22031

**Location 10:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Name:** Site 0002

- **Role:** CONTACT

**Country:** Canada

**Facility:** Local Institution - 0002

**State:** Ontario

**Zip:** M5G 2M9

**Location 11:**

**City:** Montreal

**Contacts:**

***Contact 1:***

- **Name:** Site 0003

- **Role:** CONTACT

**Country:** Canada

**Facility:** Local Institution - 0003

**State:** Quebec

**Zip:** H3T 1E2

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** BMS Clinical Trial Patient Recruiting

**URL:** https://www.bmsstudyconnect.com/s/US/English/USenHome

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000001855

- Term: Bone Marrow Diseases

- ID: D000011230

- Term: Precancerous Conditions

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10955

- Name: Leukemia, Myeloid

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: M18127

- Name: Leukemia, Myeloid, Acute

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: M14164

- Name: Preleukemia

- Relevance: HIGH

- As Found: Myelodysplastic Syndrome

- ID: M12145

- Name: Myelodysplastic Syndromes

- Relevance: HIGH

- As Found: Myelodysplastic Syndrome

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5134

- Name: Bone Marrow Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

- ID: T3995

- Name: Myeloid Leukemia

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: T182

- Name: Acute Myeloid Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T188

- Name: Acute Non Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T3993

- Name: Myelodysplastic Syndromes

- Relevance: HIGH

- As Found: Myelodysplastic Syndrome

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000007951

- Term: Leukemia, Myeloid

- ID: D000015470

- Term: Leukemia, Myeloid, Acute

- ID: D000011289

- Term: Preleukemia

- ID: D000009190

- Term: Myelodysplastic Syndromes

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
