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CompletedNCT03884556Updated Jul 2, 2025Results posted

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

A Phase 1 interventional study of TTX-030 and Pembrolizumab in Solid Tumor and Lymphoma, sponsored by Trishula Therapeutics, Inc.. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by Trishula Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Solid Tumor
  • Lymphoma

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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 56 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Trishula Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Abreviated Inclusion Criteria

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

Abbreviated Exclusion Criteria

  1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
  2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
  3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
  4. History of severe autoimmune disease
  5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Arm 1, Single Agent

    TTX-030

    Drug: TTX-030

  • Experimental
    Arm 2, Anti-PD-1 Combination

    TTX-030 plus pembrolizumab

    Drug: TTX-030 · Drug: Pembrolizumab

  • Experimental
    Arm 4, Chemotherapy Combination

    TTX-030 plus gemcitabine plus nab-paclitaxel

    Drug: TTX-030 · Drug: Gemcitabine · Drug: nab paclitaxel

Interventions

  • DrugTTX-030

    Variable dose and schedule

  • DrugPembrolizumab

    Dose and schedule per standard of care

  • DrugGemcitabine

    Dose and schedule per standard of care

  • Drugnab paclitaxel

    Dose and schedule per standard of care

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 cycle (each cycle is 21-28 days)

  2. 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

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. 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

    Time frame: Through study completion, an average of 1 year

  2. Maximum Plasma Concentration (Cmax)

    PK parameters of serum TTX-030 by Arm and Dose - Cycle 1

    Time frame: Cycles 1-3 (each cycle is 21-28 days)

07

Results

Posted Jul 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneArm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load, 30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)
Started122433681314
Completed122433681314
Not completed0000000000

Outcome measures

PrimaryNumber 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.

Time frame:
1 cycle (each cycle is 21-28 days)
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
ParticipantsArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kg
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)000000
SecondaryObjective 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

Time frame:
Through study completion, an average of 1 year
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)
percentage of participantsArm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 4 (Safety Lead-In and Expansion)
Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)1 (0.0 to 97.5)2 (0.0 to 84.2)1 (0.0 to 97.5)3 (0.0 to 70.8)2 (0.0 to 70.8)3 (0.0 to 70.8)6 (0.0 to 45.9)30.8 (9.1 to 61.4)
SecondaryMaximum Plasma Concentration (Cmax)

PK parameters of serum TTX-030 by Arm and Dose - Cycle 1

Time frame:
Cycles 1-3 (each cycle is 21-28 days)
Reported as:
Geometric mean · Cmax (μg/mL)
Maximum Plasma Concentration (Cmax)
Cmax (μg/mL)Arm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)
Maximum Plasma Concentration (Cmax)4.91 ± 025.9 ± 8.235.2 ± 6.479.3 ± 49.3188 ± 13.8190 ± 75.8629 ± 47.6694 ± 56.8647 ± 50.5487 ± 27.3
PrimaryObjective 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

Time frame:
Through study completion, an average of 1 year
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
percentage of participantsArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), Combination
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts7 (0.0 to 41)9.1 (0.2 to 41.3)

Adverse events

Collected over Up to 30 days from the last dose of TTX-030, a maximum duration of 2 years of treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: TTX-030 0.5 mg/kg0/1 (0%)0/1 (0%)1/1 (100%)
Arm 1: TTX-030 1.5 mg/kg1/2 (50%)1/2 (50%)1/2 (50%)
Arm 1: TTX-030 3.0 mg/kg1/2 (50%)1/2 (50%)2/2 (100%)
Arm 1: TTX-030 6.0 mg/kg1/4 (25%)1/4 (25%)4/4 (100%)
Arm 1: TTX-030 10 mg/kg1/3 (33.3%)1/3 (33.3%)3/3 (100%)
Arm 1: TTX-030 20 mg/kg2/3 (66.7%)0/3 (0%)3/3 (100%)
Arm 1: TTX-030 40 mg/kg3/6 (50%)4/6 (66.7%)3/6 (50%)
Arm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3W1/8 (12.5%)2/8 (25%)6/8 (75%)
Arm 2 (Safety Lead-in and Expansion), Combination4/13 (30.8%)6/13 (46.2%)13/13 (100%)
Arm 4 (Safety Lead-In and Expansion)7/14 (50%)4/14 (28.6%)14/14 (100%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventArm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)
AnemiaBlood and lymphatic system disorders0/11/20/20/40/30/31/60/81/130/14
HyperbilirubinemiaHepatobiliary disorders0/10/21/20/40/30/30/60/80/130/14
Allergy to arthropod stingImmune system disorders0/11/20/20/40/30/30/60/80/130/14
Muscular weaknessMusculoskeletal and connective tissue disorders0/10/20/20/41/30/30/60/80/130/14
SepsisInfections and infestations0/10/20/21/40/30/30/60/80/130/14
AscitesGastrointestinal disorders0/10/20/20/40/30/31/60/80/130/14
Oesophageal haemorrhageGastrointestinal disorders0/10/20/20/40/30/31/60/80/130/14
SyncopeNervous system disorders0/10/20/20/40/30/31/60/80/130/14
Confusional statePsychiatric disorders0/10/20/20/40/30/31/60/80/130/14
Urinary tract obstructionRenal and urinary disorders0/10/20/20/40/30/31/60/80/130/14
Most frequent other events
Showing 10 of 26
Most frequent other events
EventArm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)
Musculoskeletal chest painMusculoskeletal and connective tissue disorders1/10/20/21/40/30/31/60/80/130/14
FatigueGeneral disorders0/10/21/20/40/32/32/64/86/1310/14
DehydrationMetabolism and nutrition disorders0/10/20/20/40/32/31/61/81/133/14
ArthralgiaMusculoskeletal and connective tissue disorders0/11/21/20/40/30/30/62/83/133/14
Edema peripheralNervous system disorders0/10/20/20/40/30/33/60/80/134/14
HypoalbuminemiaMetabolism and nutrition disorders0/10/21/21/40/30/31/60/80/130/14
NauseaGastrointestinal disorders0/10/21/21/40/31/30/61/82/137/14
VomitingGastrointestinal disorders0/10/21/20/40/31/30/62/80/135/14
AlopeciaSkin and subcutaneous tissue disorders0/10/20/20/40/30/30/60/80/136/14
DiarrheaGastrointestinal disorders0/10/20/20/41/31/30/62/82/136/14

Baseline characteristics

Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy, or relapsed/refractory lymphoma, for which all standard therapies had been previously given.

Age, Categorical
Age, Categorical(Participants)Arm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)Total
<=18 years00000000000
Between 18 and 65 years101222449631
>=65 years021211244825
Age, Continuous
Age, Continuous(years)Arm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)Total
Median26 (26 to 26)73 (72 to 74)59.5 (54 to 65)63 (55 to 67)64 (48 to 76)59 (56 to 76)61.5 (56 to 77)64.5 (51 to 81)57 (44 to 73)66.5 (46 to 83)63.5 (26 to 83)
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)Total
Female1123312561034
Male010102437422
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)Total
American Indian or Alaska Native00000000000
Asian00000001012
Native Hawaiian or Other Pacific Islander00000001001
Black or African American01001100036
White11232266121045
More than one race00000000000
Unknown or Not Reported00010000102
Region of Enrollment
Region of Enrollment(participants)Arm 1: TTX-030 0.5 mg/kgArm 1: TTX-030 1.5 mg/kgArm 1: TTX-030 3.0 mg/kgArm 1: TTX-030 6.0 mg/kgArm 1: TTX-030 10 mg/kgArm 1: TTX-030 20 mg/kgArm 1: TTX-030 40 mg/kgArm 1 Expansion: TTX-030 40 mg/kg Load/30 mg/kg Q3WArm 2 (Safety Lead-in and Expansion), CombinationArm 4 (Safety Lead-In and Expansion)Total
United States12243368131456
08

Study locations

16 sites
  • UC Irvine Cancer Center
    Orange, California 92868, United States
  • UC Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
  • Norton Cancer Institute
    Louisville, Kentucky 40202, United States
  • Nebraska Cancer Center Oncology Hematology West P.C.
    Omaha, Nebraska 68130, United States
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Montefiore Medical Center
    The Bronx, New York 10461, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44122, United States
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • West Cancer Center and Research Institute
    Germantown, Tennessee 38138, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • NEXT Oncology
    San Antonio, Texas 78229, United States
  • Huntsman Cancer Intitute
    Salt Lake City, Utah 84112, United States
09

References and documents

Study documents

  • Study protocol · Dec 15, 2020
  • Statistical analysis plan · Sep 29, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03884556
Lead sponsor
Trishula Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 21, 2019
Start date
Apr 10, 2019
Primary completion
Nov 30, 2022
Completion
Sep 29, 2023
Results posted
Jul 2, 2025
Last update
Jul 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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