AzTrials
AzTrials

Pancreas CancerPhase 1NCT05497778

A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.

A Phase 1 study testing Gemcitabine, Nab paclitaxel and IM156 in people with Pancreas Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

To learn if adding a new medication, IM156, to treatment with gemcitabine and nab-paclitaxel is safe and tolerable. The ability of this combination to improve the success of this treatment for these patients will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
Gemcitabine, Nab paclitaxel and IM156
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
21 Oct 2022to 2 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • For inclusion in the study patients must fulfill all the following criteria:
  • Ability to understand and the willingness to sign a written informed consent form (ICF).
  • Male or female participants ≥ 18 years of age at the time of screening. Because no dosing or adverse event data are currently available on the use of IM156 in combination with Gem + NP in patients <18 years of age, children are excluded from this study.
  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
  • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [13], defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. The measurable lesion must be outside of a radiation field if the participant received prior radiation.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1).
Show all 31Show fewer
  • Naïve to any prior treatment for metastatic disease, including chemotherapy, biological therapy, or targeted therapy.
  • Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 6 months prior to study enrollment. Prior adjuvant therapy may include Gem or NP.
  • Participants initially diagnosed with localized pancreatic cancer who have undergone chemotherapy then resection and had no evidence of disease are eligible if relapse of metastatic disease has occurred and if the last dose of chemotherapy was received more than 6 months before study entry.
  • Prior radiation therapy must have been completed at least 14 days before investigational product administration.
  • Prior surgery that required general anesthesia or other major surgery as defined by the investigator must be completed at least 4 weeks before investigational product administration.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study (hormonal or barrier method of birth control; abstinence), for the duration of study participation, and 90 days after completion of IM156 administration.
  • The effects of IM156 on the developing human fetus are unknown. For this reason, all women of child-bearing potential (refer to MDA Policy CLN 1114), which includes all female patients younger than 55 years, must meet one of the following inclusion criteria:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months)
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (follicle stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy)
  • History of bilateral tubal ligation or another surgical sterilization procedure.)
  • Use of approved methods of birth control before the study, for the duration of study participation, 90 days after completion of IM156 administration, and for at least 6 months after the final dose of NP. Approved methods are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), tubal ligation or hysterectomy, patient/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. For all women of childbearing potential who do not meet one of the four criteria above, a negative serum pregnancy test will be required within 2 weeks prior to dosing.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,000/mcL (in absence of growth factor support)
  • Platelets ≥100,000/mcL
  • Hemoglobin ≥ 9.0 g/dl
  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN without hepatic metastasis and ≤ 5 x ULN with hepatic metastasis
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN without hepatic metastasis and ≤ 5 x ULN with hepatic metastasis
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Creatine clearance >50 as calculated by the Cockcroft Gault Formula
  • Patients with new brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. Patients who have undergone CNS directed treatment can be enrolled provided they show evidence of stable lesions (and no new lesions) with no evidence of tumor progression for at least 4 weeks after CNS-directed treatment. Patients do not require a baseline imaging, unless clinically indicated.

Who cannot join

  • Patients with a current evidence of diabetes mellitus who are currently being treated with another biguanide (e.g., metformin)
  • Patients who are currently being treated with the following medications, which are sensitive CYP2D6 substrates per FDA.gov (Drug Development and Interactions; Table of Substrates, Inhibitors, and Inducers): atomoxetine, desipramine, dextromethorphan , eliglustat(e), nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine
  • Patients with a history of serious gastrointestinal bleeding within 6 weeks prior to screening or patients with any disease possibly affecting the absorption of oral agents (malabsorption syndrome, hemorrhagic gastric ulcer, etc.)
  • Patients with suspected serious infectious diseases, intestinal paralysis, bowel obstruction, interstitial pneumonia, or pulmonary fibrosis.
  • Patients with a history of alcohol or drug abuse within 12 weeks prior to screening
  • The effects of IM156 on the developing human fetus are unknown. For this reason, women who are pregnant or breastfeeding are excluding from this study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Show all 15Show fewer
  • Patients with uncontrolled underlying medical conditions (e.g., interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms, symptomatic congestive heart failure [New York Heart Association class III or IV], unstable angina, uncontrolled hypertension, cardiac arrhythmia, interstitial lung disease, active coagulopathy).
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
  • Any active autoimmune disease.
  • Any concurrent investigational anticancer therapy.
  • Any concurrent immunosuppressive medications, including chronic systemic corticosteroids at greater than physiologic doses (a dose of 10 mg/day oral prednisone or equivalent) 14 days before the first dose (except for participants who require hormone replacement therapy such as hydrocortisone). A temporary course (≤ 3 days) of corticosteroids (i.e., contrast allergy, chronic obstructive pulmonary disease) may be permitted, depending on the duration and dose, after discussion and agreement with the PI.
  • Any concurrent chemotherapy, radiotherapy (except palliative radiotherapy), immunotherapy, biologic, or hormonal treatment. Concurrent use of hormones for noncancer-related conditions is permitted.
  • Patients who have not recovered from adverse events due to prior anticancer therapy (i.e., have residual toxicities > Grade 1) except for alopecia.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to IM156, Gem or NP.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

To learn if adding a new medication, IM156, to treatment with gemcitabine and nab-paclitaxel is safe and tolerable. The ability of this combination to improve the success of this treatment for these patients will also be studied.

Read the detailed description

Primary Safety Objective:

To evaluate the safety and tolerability of IM156 with Gem+NP in patients with metastatic PDAC

Exploratory Efficacy Objective:

To evaluate the efficacy of IM156 with Gem+NP in patients with metastatic PDAC

Exploratory Biomarker Objective:

To identify biomarkers that are predictive of response to IM156 (i.e., predictive biomarkers), are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with resistance to IM156, are associated with susceptibility to developing adverse events, can provide evidence of study treatment activity, or can increase the knowledge and understanding of disease biology.

Conditions
Pancreas Cancer
Being tested
Gemcitabine, Nab paclitaxel, IM156
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • GemcitabineDrug

    Also called Gemcitabine Hydrochloride, Gemzar®

    Given by IV (vein)

  • Nab paclitaxelDrug

    Also called Paclitaxel (protein-bound), Abraxane, ABI-007

    Given by IV (vein)

  • IM156Drug

    Given by PO

Study groups in NCT05497778
Study groupRoleWhat they receive
Dose Escalation Phase followed by a Dose Expansion PhaseExperimentalIn the Dose Escalation Phase of the study, we will identify the RPD2 of IM156. Subsequently, we will evaluate IM156 at the RP2D (established in the Dose Expansion Phase) and gemcitabine + nab-paclitaxel in the Dose Expansion Phase.
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: IM156

What is being measured

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

  1. National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0

    Measured: through study completion and or average of 1 year

Timeline

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

  1. First posted11 Aug 2022
  2. Study start21 Oct 2022
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497778
Sponsor's protocol ID
2022-0130
Other IDs
NCI-2022-06636
Status last verified
Oct 2026
First submitted
8 Aug 2022
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Nab paclitaxel and IM156 in people with Pancreas Cancer, run by M.D. Anderson Cancer Center at 1 site 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?

The sponsor lists 31 inclusion and 15 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (time frame: through study completion and or average of 1 year). 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 NCT05497778.

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 7 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in