## Protocol Section
### Identification Module
**NCT ID:** NCT06418061

**Brief Title:** Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

**Official Title:** A Phase 1, Multicenter, Open-label Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

#### Organization Study ID Info
**ID:** CIBI3005A101
#### Organization
**Class:** INDUSTRY
**Full Name:** Innovent Biologics (Suzhou) Co. Ltd.
### Status Module
#### Completion Date
**Date:** 2027-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Innovent Biologics (Suzhou) Co. Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.

### Conditions Module

**Conditions:**

- Solid Tumors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 198

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: IBI3005

**Label:** IBI3005

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IBI3005

**Description:** Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)

**Name:** IBI3005

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

**Measure:** Number of subjects with adverse events

**Time Frame:** up to 3 years

**Description:** Clinically significant abnormal physical examination findings reported by the investigator.

**Measure:** Number of subjects with clinically significant changes in physical examination results

**Time Frame:** up to 3 years

**Description:** Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

**Measure:** Number of subjects with clinically significant changes in vital signs

**Time Frame:** up to 3 years

**Description:** Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.

**Measure:** Dose limiting toxicities (DLTs)

**Time Frame:** Up to 4 weeks

#### Secondary Outcomes

**Description:** area under the curve (AUC) of single and multiple doses of IBI3005

**Measure:** area under the curve (AUC)

**Time Frame:** up to 3 years

**Description:** maximum concentration (Cmax) of single and multiple doses of IBI3005

**Measure:** maximum concentration (Cmax)

**Time Frame:** up to 3 years

**Description:** time to maximum concentration (Tmax) of single and multiple doses of IBI3005

**Measure:** time to maximum concentration (Tmax)

**Time Frame:** up to 3 years

**Description:** clearance (CL) of single and multiple doses of IBI3005

**Measure:** clearance (CL)

**Time Frame:** up to 3 years

**Description:** apparent volume of distribution (V) of single and multiple doses of IBI3005

**Measure:** apparent volume of distribution (V)

**Time Frame:** up to 3 years

**Description:** half-life (t1/2) of IBI3005 to the last administration of IBI3005

**Measure:** half-life (t1/2)

**Time Frame:** up to 3 years

**Description:** Incidence and characterization of anti-drug antibody (ADA).

**Measure:** anti-drug antibody (ADA)

**Time Frame:** up to 3 years

**Description:** objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.

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

**Time Frame:** up to 3 years

**Description:** duration of response (DoR) as evaluated per the RECIST v1.1 criteria.

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

**Time Frame:** up to 3 years

**Description:** time to response (TTR) as evaluated per the RECIST v1.1 criteria.

**Measure:** time to response (TTR)

**Time Frame:** up to 3 years

**Description:** as evaluated per the RECIST v1.1 criteria.

**Measure:** progression free survival (PFS)

**Time Frame:** up to 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerant of standard treatment, or for which no standard treatment is available；

Exclusion Criteria:

1. Enrolled in any other interventional clinical research unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
2. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) prior to first administration of the study drug；
3. Multiple concurrent malignant tumors within 5 years: except adequately resected non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured;
4. Allergic or hypersensitive to other monoclonal antibodies and/or exatecan or other camptothecin-derived agents (e.g., topotecan) based therapy, or any ingredients of IBI3005;
5. Not eligible to participate in this study at the discretion of the investigator.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nedlands

**Contacts:**

***Contact 1:***

- **Email:** azim.khan@oneclinicalresearch.com.au

- **Name:** Azim Khan

- **Phone:** 08 6279 9466

- **Role:** CONTACT

**Country:** Australia

**Facility:** One Clinical Research Pty Ltd

**State:** Western Australia

**Zip:** 6009

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M5426

- Name: Camptothecin

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
