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Non-small Cell Lung CancerPhase 1NCT04314089

Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage Non-Small Cell Lung Cancer (TOP 1902)

A Phase 1 study testing GT103 in people with Non-small Cell Lung Cancer, run by Edward Patz at 3 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

The purpose of this research study is to determine the maximum tolerated dose of GT103 and investigate the safety and effectiveness of the study drug. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
GT103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
3 sitesUnited States
Study dates
9 Jun 2020to 30 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically and/or cytologically confirmed advanced stage III, IV or recurrent NSCLC whose tumors have progressed on prior therapy.
  • Prior Therapy:
  • Patients must have received immunotherapy (anti-PD-1/PD-Ll) and a platinum- based chemotherapy either concomitantly or sequentially. There is no defined window of time since receiving immunotherapy. Immunotherapy does not have to be the immediate treatment prior to this protocol therapy.
  • Patients with EGFR, ALK, or ROS1 alterations must have received at least one prior TKI and prior chemotherapy (at least one platinum doublet regimen).
  • Stage III patients:
  • If previously treated with immunotherapy participants with investigator-assessed radiographic disease progression or recurrence in less than 6 months after the last dose of immunotherapy in Stage III B/C disease post concurrent chemoradiotherapy followed by immunotherapy are eligible. Radiographic progression must be documented via pretreatment scan as compared to the prior therapy baseline scan in order for the participant to be eligible.
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  • Disease must be measurable by RECIST 1.1 criteria (see Appendix A). Tumor lesions in a previously irradiated area are considered measurable IF progression has been demonstrated in such lesions after radiation.
  • Age ≥ 18 years
  • ECOG Performance Status 0 or 1 (see Appendix B)
  • Adequate bone marrow function as shown by:
  • ANC ≥ 1.5 x 109
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL; Erythropoietin and transfusion support is permitted. If patient is receiving supportive care, hemoglobin must be stable above or equal to 9 g/dL for at least 2 weeks prior to day 1 of study drug without blood transfusion to maintain hemoglobin level.
  • Adequate liver function as shown by:
  • serum bilirubin ≤ 1.5x ULN
  • ALT and AST ≤ 2.5x ULN ; ≤ 5 x ULN with liver metastasis
  • Adequate renal function: defined as creatinine clearance (estimated) ≥ 50 cc/min by Cockroft Gault or 24-hour urine (see Appendix E).
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and prior to treatment on Cycle 1 Day 1; both men and women must be willing to use two medically accepted methods of contraception, one of them being a barrier method during the study and for 6 months after last study drug administration. See Section 6.3.1.1 for a list of acceptable methods of contraception.
  • Signed informed consent
  • Willing and able to comply with clinic visits and study-related procedures and requirements.

Who cannot join

  • Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks from day 1 of study drug (including investigational agents, chemotherapy, and antibody-based therapy).
  • Patients currently receiving extracranial palliative radiation within 2 weeks from day 1 of study drug.
  • Patients who:
  • Have had a major surgery or significant traumatic injury within 4 weeks from day 1 of study drug,
  • Have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or
  • Are anticipated to require major surgery during the course of the study.
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  • Intolerance to PD-1/PD-L1 axis drug(s), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immune-stimulatory anti-tumor agents. (Intolerance: Toxicity that warrant no subsequent/further PD-1/PD-L1 therapy).
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent with the following exceptions:
  • Intermittent steroids (not to exceed prednisone 10 mg every day or equivalent dosing) may be used on an as-needed basis (e.g., treatment for chemotherapy- related nausea, anorexia and fatigue.)
  • Patients on physiologic replacement doses of steroids due to adrenal insufficiency for any reason may remain on these medications.
  • Topical, inhaled or intra-articular corticosteroids
  • Symptomatic brain or leptomeningeal metastases, including patients who continue to require glucocorticoids and/or antiseizure therapy for brain or leptomeningeal metastases.
  • Treated, asymptomatic metastases are permitted provided the patient has completed radiation at least 2 weeks prior to day 1 and has been off steroids for at least 2 weeks prior to day 1 of study drug.
  • Stable (MRI or CT with contrast performed >4 weeks apart), untreated brain metastases are permitted if patient does not require steroids and/or antiseizure therapy is not required.
  • Presence of poorly controlled atrial fibrillation (ventricular heart rate >100 bpm) by EKG.
  • Previous history of CVA, TIA, angina pectoris, acute MI or history of recent re-perfusion procedures (e.g., PTCA), pulmonary embolus or untreated deep vein thrombosis within 6 months from day 1 of study drug. NOTE: Subjects with recent deep vein thrombosis and/or pulmonary embolus who have been therapeutically anti-coagulated for at least 6 weeks are eligible.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. Examples include but are not limited to:
  • Active (acute or chronic) infections requiring treatment with antibiotics.
  • Liver disease such as cirrhosis, chronic active or persistent hepatitis B or C or HIV.
  • Age related macular degeneration, atypical hemolytic uremia syndrome, glomerulonephritis, or known autoimmune diseases.
  • A concurrent diagnosis of a separate malignancy is allowed if clinically stable and does not require tumor-directed therapy
  • History of interstitial pneumonitis of autoimmune etiology (including immune checkpoint pneumonitis) which has been symptomatic and/or required treatment. History of radiation pneumonitis is allowed if the patient has recovered and does not currently require steroid therapy.
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1 of study drug
  • Known autoimmune conditions requiring systemic immune suppressive therapy other than prednisone less than or equal to 10 mg.
  • Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS).
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. See Section 6.3.1.1 for a complete list of medically acceptable birth control methods.
  • Corrected QTc interval > 480 msec. If QTc interval is > 480 msec, then 2 additional ECGs should be obtained over a brief period (e.g., within 15-20 minutes) to confirm the abnormality. The average QTc interval will be determined from the 3 ECG tracings by manual evaluation and will be used to determine if the subject will be excluded from the study. The same method of QTc determination must be used throughout the subject's participation in the trial.
  • Patients unwilling to or unable to comply with the protocol.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Advent Health

    Celebration, Florida, 34747

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27540

Other trials in United States

About this study

The purpose of this research study is to determine the maximum tolerated dose of GT103 and investigate the safety and effectiveness of the study drug.

Read the detailed description

This is a Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage (III/IV) and Recurrent Non-Small Cell Lung Cancer.

Patients with histologically confirmed recurrent, advanced stage of lung cancer, and there are no other standard therapies available may be eligible to participate in this study.

Being tested
GT103
Keywords
Stage III/IV NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • GT103Drug

    intravenously (dose depending)

Study groups in NCT04314089
Study groupRoleWhat they receive
GT103ExperimentalParticipants will receive GT103 every 3 weeks. GT103 will be escalated from .3mg/kg up 10 to mg/kg or until MTD is found
Receives: Drug: GT103

What is being measured

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

  1. To determine the maximum tolerated dose (MTD), if any

    The number and proportion of subjects at each dose level who experience a DLT

    Measured: 2 years

  2. Time for the concentration of GT103 to reach half of the level administered

    Measured: 2 years

  3. Recommended phase II dose (RP2D) of GT103

    Recommended dose for the Phase II portion of the study

    Measured: 2 years

Secondary outcomes (3)

  1. Response Rate

    Response rate is defined as the proportion of treated subjects with a complete or partial response. The response rate associated with the dose chosen to be the RP2D will also be estimated.

    Measured: 2 years

  2. Progression-Free Survival

    PFS is defined as the time between initiation of treatment and initial failure (disease progression or death). If the patient remains alive without disease progression at the time of analysis, PFS will be censored at the time of last follow-up. If the patient starts alternative anti-cancer therapy before progression, PFS will be censored at the time that the alternative treatment is initiated.

    Measured: 2 years

  3. Overall Survival

    OS is defined as the time between initiation of treatment and death.

    Measured: 2 years

Timeline

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

  1. First posted18 Mar 2020
  2. Study start9 Jun 2020
  3. Primary completion11 Apr 2024
  4. Study completion30 Dec 2024

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314089
Sponsor's protocol ID
Pro00104564
Status last verified
Jun 2025
First submitted
16 Mar 2020
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Clarke JM, Simon GR, Mamdani H, Gu L, Herndon JE 2nd, Stinchcombe TE, Ready N, Crawford J, Sonpavde G, Balevic S, Nixon AB, Campa M, Gottlin EB, Li H, Saxena R, He YW, Antonia S, Patz EF Jr. Complement factor H targeting antibody GT103 in refractory non-small cell lung cancer: a phase 1b dose escalation trial. Nat Commun. 2025 Jan 2;16(1):93. doi: 10.1038/s41467-024-55092-2.

    PubMed 39747856

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GT103 in people with Non-small Cell Lung Cancer, run by Edward Patz at 3 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?

The sponsor lists 20 inclusion and 28 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: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the maximum tolerated dose (MTD), if any (time frame: 2 years). The study lists 3 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 NCT04314089, which also lists 1 linked publication.

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 17 Jun 2025.

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