Solid TumorPhase 1NCT03884556

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

A Phase 1 study testing TTX-030, Pembrolizumab and Gemcitabine in people with Solid Tumor and Lymphoma, run by Trishula Therapeutics, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Lymphoma
What is being tested?: TTX-030, Pembrolizumab and Gemcitabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 16 sitesUnited States
Study dates: 10 Apr 2019to 29 Sep 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Abreviated Inclusion Criteria

Advanced solid tumor malignancy or relapsed/refractory lymphoma, or

eligible to receive single-agent pembrolizumab as standard of care, or
eligible to receive single-agent docetaxel as standard of care, or
advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.

Age 18 years or older, is willing and able to provide informed consent
Evidence of measurable disease
Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Abbreviated Exclusion Criteria

History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
History of severe autoimmune disease
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44122
West Cancer Center and Research Institute
Germantown, Tennessee, 38138
Norton Cancer Institute
Louisville, Kentucky, 40202
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Columbia University Irving Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Nebraska Cancer Center Oncology Hematology West P.C.
Omaha, Nebraska, 68130
UC Irvine Cancer Center
Orange, California, 92868
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Intitute
Salt Lake City, Utah, 84112
NEXT Oncology
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.

Conditions: Solid Tumor, Lymphoma
Being tested: TTX-030, Pembrolizumab, Gemcitabine, nab paclitaxel
Keywords: Cancer, Metastatic Solid Tumors, Advanced Solid Tumors, Relapsed/Refractory Lymphoma, Prostrate Cancer, Pancreatic Cancer, Monotherapy, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, PD-1, Checkpoint Inhibitor, Nab-paclitaxel, Gemcitabine, Pembrolizumab, Docetaxel, Bladder Cancer, Lung Cancer
Medical subject headings: Lymphoma, Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TTX-030Drug
Variable dose and schedule
PembrolizumabDrug
Dose and schedule per standard of care
GemcitabineDrug
Dose and schedule per standard of care
nab paclitaxelDrug
Dose and schedule per standard of care

Study groups in NCT03884556
Study group	Role	What they receive
Arm 1, Single Agent	Experimental	TTX-030 Receives: Drug: TTX-030
Arm 2, Anti-PD-1 Combination	Experimental	TTX-030 plus pembrolizumab Receives: Drug: TTX-030; Drug: Pembrolizumab
Arm 4, Chemotherapy Combination	Experimental	TTX-030 plus gemcitabine plus nab-paclitaxel Receives: Drug: TTX-030; Drug: Gemcitabine; Drug: nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs.
During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.
Measured: 1 cycle (each cycle is 21-28 days)
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Measured: Through study completion, an average of 1 year
Maximum Plasma Concentration (Cmax)
PK parameters of serum TTX-030 by Arm and Dose - Cycle 1
Measured: Cycles 1-3 (each cycle is 21-28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201929 Sep 2023

First posted21 Mar 2019
Study start10 Apr 2019
Primary completion30 Nov 2022
Study completion29 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03884556
Sponsor's protocol ID: TTX-030-001
Status last verified: Jun 2025
First submitted: 16 Mar 2019
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of MGC030 in Participants With Advanced Solid Tumors
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All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT03884556
Acronym / sponsor ID: TTX-030-001
Conditions: Solid Tumor, Lymphoma
Keywords: Cancer, Metastatic Solid Tumors, Advanced Solid Tumors, Relapsed/Refractory Lymphoma, Prostrate Cancer, Pancreatic Cancer, Monotherapy, Combination Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Trishula Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 10 Apr 2019 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 29 Sep 2023 (actual)
First posted: 21 Mar 2019 (actual)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm 1, Single Agent	Experimental	Drug: TTX-030TTX-030
Arm 2, Anti-PD-1 Combination	Experimental	Drug: TTX-030, Drug: PembrolizumabTTX-030 plus pembrolizumab
Arm 4, Chemotherapy Combination	Experimental	Drug: TTX-030, Drug: Gemcitabine, Drug: nab paclitaxelTTX-030 plus gemcitabine plus nab-paclitaxel

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TTX-030Variable dose and schedule	Drug	Arm 1, Single Agent, Arm 2, Anti-PD-1 Combination, Arm 4, Chemotherapy Combination
PembrolizumabDose and schedule per standard of care	Drug	Arm 2, Anti-PD-1 Combination
GemcitabineDose and schedule per standard of care	Drug	Arm 4, Chemotherapy Combination
nab paclitaxelDose and schedule per standard of care	Drug	Arm 4, Chemotherapy Combination

Primary outcome

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: 1 cycle (each cycle is 21-28 days)
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
Time frame: Through study completion, an average of 1 year
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens

2 secondary outcomes

Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)
Time frame: Through study completion, an average of 1 year
Maximum Plasma Concentration (Cmax)
Time frame: Cycles 1-3 (each cycle is 21-28 days)

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: TTX-030 0.5 mg/kg	1	1
Arm 1: TTX-030 1.5 mg/kg	2	2
Arm 1: TTX-030 3.0 mg/kg	2	2
Arm 1: TTX-030 6.0 mg/kg	4	4
Arm 1: TTX-030 10 mg/kg	3	3
Arm 1: TTX-030 20 mg/kg	3	3
Arm 1: TTX-030 40 mg/kg	6	6
Arm 1 Expansion: TTX-030 40 mg/kg Load, 30 mg/kg Q3W	8	8
Arm 2 (Safety Lead-in and Expansion), Combination	13	13
Arm 4 (Safety Lead-In and Expansion)	14	14

Primary outcome: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Time frame: 1 cycle (each cycle is 21-28 days). Count of participants. Unit: Participants

Measure	Arm 1: TTX-030 1.5 mg/kg n = 2	Arm 1: TTX-030 3.0 mg/kg n = 2	Arm 1: TTX-030 6.0 mg/kg n = 3	Arm 1: TTX-030 10 mg/kg n = 3	Arm 1: TTX-030 20 mg/kg n = 3	Arm 1: TTX-030 40 mg/kg n = 6
Value	0	0	0	0	0	0

Population analysed: All participants in the Dose Escalation cohorts who received 1 infusion during the treatment cycle and completed safety evaluations through the end of the DLT period or experienced a DLT before the end of the DLT period (ie, participants started Cycle 2 or experienced a DLT).

Primary outcome: Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts

Time frame: Through study completion, an average of 1 year. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W n = 7	Arm 2 (Safety Lead-in and Expansion), Combination n = 11
Value	7 (0.0 to 41)	9.1 (0.2 to 41.3)

Population analysed: Participants in the Safety Analysis Set who had at least 1 post baseline evaluable tumor assessment unless death or clinical progressive disease (PD) occurred before the first post baseline disease assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: TTX-030 0.5 mg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Arm 1: TTX-030 1.5 mg/kg	1 of 2 (50%)	1 of 2 (50%)	1 of 2
Arm 1: TTX-030 3.0 mg/kg	1 of 2 (50%)	2 of 2 (100%)	1 of 2
Arm 1: TTX-030 6.0 mg/kg	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Arm 1: TTX-030 10 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Arm 1: TTX-030 20 mg/kg	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Arm 1: TTX-030 40 mg/kg	4 of 6 (66.7%)	3 of 6 (50%)	3 of 6
Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W	2 of 8 (25%)	6 of 8 (75%)	1 of 8
Arm 2 (Safety Lead-in and Expansion), Combination	6 of 13 (46.2%)	13 of 13 (100%)	4 of 13
Arm 4 (Safety Lead-In and Expansion)	4 of 14 (28.6%)	14 of 14 (100%)	7 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TTX-030, Pembrolizumab and Gemcitabine in people with Solid Tumor and Lymphoma, run by Trishula Therapeutics, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (time frame: 1 cycle (each cycle is 21-28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03884556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.