JAB-3312 Activity in Adult Patients With Advanced Solid Tumors

• Sponsor: Jacobio Pharmaceuticals Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04720976
• Collaborator: AbbVie (Industry)
• Enrollment: 200
• Locations: 7
• Arms: 8
• Anticipated Duration (Months): 27.2
• Patients Per Site: 28.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult	Drug: JAB-3312; Drug: Binimetinib; Drug: Pembrolizumab; Drug: Sotorasib; Drug: Osimertinib	Phase 1/Phase 2

Detailed Description

To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors
• Actual Study Start Date: Mar 23, 2021
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JAB-3312+Pembrolizumab dose escalation Dose escalation part 1	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Pembrolizumab; Pembrolizumab will be administered as an intravenous infusion.
Experimental: JAB-3312+ Binimetinib dose escalation Dose escalation part2	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Binimetinib; Binimetinib will be administered orally.
Experimental: JAB-3312+Pembrolizumab dose expansion Dose expansion part1	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Pembrolizumab; Pembrolizumab will be administered as an intravenous infusion.
Experimental: JAB-3312+Binimetinib dose expansion Dose expansion part2	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Binimetinib; Binimetinib will be administered orally.
Experimental: JAB-3312+Sotorasib dose escalation Dose escalation part3	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Sotorasib; Sotorasib will be administered orally.
Experimental: JAB-3312+ Osimertinib dose escalation Dose escalation part4	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Osimertinib; Osimertinib will be administered orally.
Experimental: JAB-3312+ Sotorasib dose expansion Dose expansion part3	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Sotorasib; Sotorasib will be administered orally.
Experimental: JAB-3312+ Osimertinib dose expansion Dose expansion part4	Drug: JAB-3312; JAB-3312 will be administered orally, variable dose.; Drug: Osimertinib; Osimertinib will be administered orally.

Outcome Measures

Primary Outcome Measures

1. Number of participants with dose limiting toxicities [24 months]

   Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

2. Objective response rate (ORR) [24 months]

   ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)

3. Duration of response (DOR) [24 months]

   DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)

4. Duration of response (DCR) [24 months]

   DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)

5. Progression-free survival (PFS) [24 months]

   PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)

6. Overall survival (OS) [24 months]

   OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)

7. Number of participants with adverse events [24 months]

   All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments

Secondary Outcome Measures

1. Objective response rate (ORR) [24 months]

   ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)

2. Duration of response ( DOR ) [24 months]

   DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose escalation phase)

3. Duration of response ( DCR ) [24 months]

   DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)

4. Progression-free survival (PFS) [24 months]

   PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose escalation phase)

5. Overall survival (OS) [24 months]

   OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)

6. Plasma concentration (Cmax) [24 months]

   Highest observed plasma concentration of JAB-3312(dose escalation phase)

7. Time to achieve Cmax (Tmax) [24 months]

   Time of highest observed plasma concentration of JAB-3312(dose escalation phase)

8. Area under the plasma concentration-time curve (AUC) [24 months]

   Area under the plasma concentration time curve of JAB-3312(dose escalation phase)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.

• Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Sufficient organ function

• Participants with a life expectancy ≥3 months

• Participants must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria:

• History of cancer that is histologically distinct from the cancers under study

• Brain or spinal metastases

• History of severe autoimmune disease or autoimmune disorder that requires chronic systemic corticosteroid treatment.

• Has active hepatitis B, or hepatitis C infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Phoenix	Arizona	United States	85054
2	Research Site	Scottsdale	Arizona	United States	85259
3	Research Site	Jacksonville	Florida	United States	32224
4	Research Site	Detroit	Michigan	United States	48202
5	Research Site	Saint Louis	Missouri	United States	63130
6	Research Site	Houston	Texas	United States	77030
7	Research Site	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Jacobio Pharmaceuticals Co., Ltd.
• AbbVie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04720976
• Other Study ID Numbers: JAB-3312-1003
• First Posted: Jan 22, 2021
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Pembrolizumab; Osimertinib

Study Results

No Results Posted as of Jan 19, 2022