Trial Outcomes & Findings for A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors (NCT NCT05001347)
NCT ID: NCT05001347
Last Updated: 2025-12-16
Results Overview
Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on RECIST 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 66 weeks
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
Cohort 1
Platinum resistant or refractory IO naive ovarian carcinoma (OC)
TJ004309 20mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
Cohort 2
HNSCC, NSCLC, GC, TNBC, OC
TJ004309 20 mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
8
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
14
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1
n=17 Participants
Platinum resistant or refractory IO naive ovarian carcinoma (OC)
TJ004309 20mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
Cohort 2
n=8 Participants
HNSCC, NSCLC, GC, TNBC, OC
TJ004309 20 mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 10.84 • n=6 Participants
|
60.0 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=6 Participants
|
8 participants
n=5 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 66 weeksPopulation: Efficacy evaluable analysis set was defined as all patients who received at least one dose of study drug and undergo at least one post-baseline tumor assessment. Patients who died before the first scheduled post-baseline tumor assessment were also included in the efficacy evaluable analysis set- only 23 of the 25 subjects were efficacy evaluable per this definition.
Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on RECIST 1.1
Outcome measures
| Measure |
Cohort 1
n=15 Participants
Platinum resistant or refractory IO naive ovarian carcinoma (OC)
TJ004309 20mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
Cohort 2
n=8 Participants
HNSCC, NSCLC, GC, TNBC, OC
TJ004309 20 mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
|---|---|---|
|
To Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 66 weeksPopulation: Overall number of participants is the number of subjects who had at least one response assessment (iRECIST) from N=6 out 15 in Cohort 1 and N=4 out of 8 in Cohort 2
Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on iRECIST.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Platinum resistant or refractory IO naive ovarian carcinoma (OC)
TJ004309 20mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
Cohort 2
n=4 Participants
HNSCC, NSCLC, GC, TNBC, OC
TJ004309 20 mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
|---|---|---|
|
o Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 7 serious events
Other events: 0 other events
Deaths: 4 deaths
Cohort 2
Serious events: 4 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1
n=17 participants at risk
Platinum resistant or refractory IO naive ovarian carcinoma (OC)
TJ004309 20mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
Cohort 2
n=8 participants at risk
HNSCC, NSCLC, GC, TNBC, OC
TJ004309 20 mg/kg Q3W and atezolizumab 1200 mg/flat dose Q3W
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
23.5%
4/17 • 15 months
|
25.0%
2/8 • 15 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • 15 months
|
12.5%
1/8 • 15 months
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
0.00%
0/17 • 15 months
|
12.5%
1/8 • 15 months
|
|
Cardiac disorders
Cardiac Failure congestive
|
0.00%
0/17 • 15 months
|
12.5%
1/8 • 15 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.9%
1/17 • 15 months
|
0.00%
0/8 • 15 months
|
|
General disorders
Asthenia
|
5.9%
1/17 • 15 months
|
0.00%
0/8 • 15 months
|
|
Hepatobiliary disorders
Biliary Obstruction
|
5.9%
1/17 • 15 months
|
0.00%
0/8 • 15 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • 15 months
|
12.5%
1/8 • 15 months
|
|
Renal and urinary disorders
Ureteric obstruction
|
5.9%
1/17 • 15 months
|
0.00%
0/8 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.9%
1/17 • 15 months
|
0.00%
0/8 • 15 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place