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Carcinoma, Basal CellPhase 1NCT03897036

Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)

A Phase 1 study testing CX-4945 in people with Carcinoma, Basal Cell, run by Senhwa Biosciences, Inc. at 6 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 study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Basal Cell
What is being tested?
CX-4945
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesUnited States
Study dates
16 Apr 2019to 25 Jan 2024
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

Who may be able to join

  • Signed, written IRB-approved informed consent.
  • Men and women age ≥ 18 years
  • ECOG Performance status 0 or 1
  • For patients with mBCC, histologic confirmation of distant BCC metastasis (e.g., lung, liver, lymph nodes, or bone), with metastatic disease that is RECIST measurable using CT or MRI
  • Phase I Expansion:
  • If a patient with locally advanced BCC also has a tumor that is not contiguous with cutaneous BCC, e.g., regional lymph nodes (if confirmed on biopsy as BCC and RECIST measurable), the patients should be considered as having mBCC and should be enrolled in the mBCC cohort
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  • For patients with locally advanced BCC, histologically confirmed disease with at least one lesion that was 10 mm or more in at least 1 dimension by color photograph that is considered to be inoperable or medical contraindication to surgery (see below), in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon
  • Acceptable medical contraindications to surgery include:
  • BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely
  • Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
  • Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.
  • For all patients, smoothened inhibitor must have been previously administered for their locally advanced or metastatic BCC, unless smoothened inhibitor is inappropriate (e.g., patient has received a smoothened inhibitor but became intolerant to the therapy). For patients whose BCC has been treated with smoothened inhibitor, disease must have progressed after treatment.
  • For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
  • Previous Therapy
  • Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred.
  • Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.
  • Other Systemic Therapy: Previous treatment with Hh pathway antagonists is not allowed (except for Smoothened inhibitors). There is no limit to the other prior therapies received
  • Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:
  • Longest of one of the following:
  • Two weeks,
  • 5 half-lives for investigational agents,
  • For anti-cancer therapies with half-lives > 8 days, a washout period of at least 28 days will be acceptable,
  • Standard cycle length of standard therapies.
  • Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above.
  • For patients with locally advanced BCC, willingness to consent to biopsy of tumor(s) at baseline and during the study, as mandated by the protocol
  • Adequate hematopoietic capacity, as defined by the following:
  • Hemoglobin ≥ 9.0 g/dL and not transfusion dependent
  • Platelets ≥ 100,000/mm3
  • Absolute neutrophil count ≥ 1500 cells/mm3
  • Adequate hepatic function, as defined by the following:
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present
  • Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease
  • Albumin ≥ 3.0 g/dL
  • Adequate renal function, as defined by the following:
  • Renal: calculated creatinine clearance >45 mL/min for patients with abnormal, increased, creatinine levels (Cockcroft-Gault formula).
  • Women/men of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of CX-4945 (see Appendix D for definition of women of childbearing potential and acceptable and unacceptable methods of contraception)

Who cannot join

  • Tumor histology consistent with basosquamous carcinoma (basal cell carcinoma with squamous differentiation or metatypical carcinoma).
  • Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
  • Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)
  • For patients with multiple cutaneous BCCs at baseline that are not designated by the investigator as target lesions, treatment of these non-target BCCs with surgery may be permitted but must be discussed with the Medical Monitor prior to any surgical procedure.
  • For patients with locally advanced BCC whose target lesion(s) is/are inoperable at baseline but is/are later deemed potentially operable because of tumor response to CX-4945, surgery with curative intent may be permitted but must be discussed with the Medical Monitor prior to any surgical procedure.
  • History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix
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  • Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications
  • Difficulty with swallowing oral medications
  • Chronic diarrhea (excess of 2-3 stools/day above normal frequency)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • HonorHealth Research & Innovation Institute

    Scottsdale, Arizona, 85258

  • H. Lee Moffitt Cancer Center & Research Institute, Inc.

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients With Advanced Basal Cell Carcinoma

This study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC). The safety and tolerability of CX-4945, preliminary evidence of antitumor effect, and the effect of CX-4945 treatment on the Hh signaling pathway will also be evaluated in this study.

Read the detailed description

Basal cell carcinomas require the hedgehog (Hh) pathway for growth. Hh binding relieves the inhibitory effect of PTCH1 on Smoothened (SMO). Signal transduction by SMO then leads to the activation and nuclear localization of GLI1 transcription factors and induction of Hh target genes, many of which are involved in proliferation, survival, and angiogenesis. Hedgehog pathway inhibitors, such as vismodegib6 and sonidegib phosphate, target the G-protein-coupled receptor Smoothened (SMO) and are recommended as first-line treatment for advanced BCC or mBCC by the National Comprehensive Cancer Network. CK2 affects the terminal-most Hh signaling components. Given the roles of CK2 on the terminal step of the hedgehog signaling pathway, CK2 inhibition is unlikely to be overcome by downstream mutations within this pathway. These data thus suggest an immediately practical application of CX-4945 in Hh-driven tumors and possibly tumors resistant to SMO inhibitors.

Being tested
CX-4945
Keywords
Advanced Basal Cell Carcinoma, laBCC, Locally Advanced Basal Cell Carcinoma, mBCC, Metastatic Basal Cell Carcinoma
Medical subject headings
Carcinoma, Basal Cell

What participants receive

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

  • CX-4945Drug

    API powder-in-capsule in 200 mg strength

Study groups in NCT03897036
Study groupRoleWhat they receive
Treatment-Duration-IncrementExperimentalCX-4945 capsules at 1000mg BID x 28 days/cycle
Receives: Drug: CX-4945
ExpansionExperimentalCX-4945 capsules at 1000mg BID x 28 days/cycle
Receives: Drug: CX-4945

What is being measured

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

  1. Determination of RP2D

    Determination of RP2D for the expansion cohorts

    Measured: Cycle 1, twenty-eight (28) day continuous dosing schedule

Timeline

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

  1. First posted1 Apr 2019
  2. Study start16 Apr 2019
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03897036
Sponsor's protocol ID
CX-4945-07
Status last verified
May 2025
First submitted
28 Mar 2019
Last updated
20 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CX-4945 in people with Carcinoma, Basal Cell, run by Senhwa Biosciences, Inc. at 6 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 36 inclusion and 10 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 20 May 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?

Determination of RP2D (time frame: Cycle 1, twenty-eight (28) day continuous dosing schedule). 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 NCT03897036.

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 20 May 2025.

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